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"True Indicating, LLC", "device": "InstaTRU Instant Biological Indicator for Steam (IBI-05)", "category": "General Hospital", "specialty": "General Hospital", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-05-21", "product_code": "QVB", "device_class": "2", "state": "OH", "country": "US", "review_days": 393, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251559", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252066", "pathway": "510(k)", "company": "Vincent Healthcare Products Limited", "parent": "Vincent Healthcare Products Limited", "device": "inspired\u0099 Heated Breathing Circuit (510-008); inspired\u0099 Heated Breathing Circuit (510-009); inspired\u0099 Auto-feed Humidification Chamber (VHC10); inspired\u0099 Auto-feed Humidification Chamber (VHC20)", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-07-01", "product_code": "BZE", "device_class": "2", "state": "", "country": "HK", "review_days": 352, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252066", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253116", "pathway": "510(k)", "company": "The Surgeon General, Department of the Army (TSG-DA)", "parent": "The Surgeon General, Department of the Army (TSG-DA)", "device": "3D MAC Titanium Cranial Plate (TCP) System", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-09-24", "product_code": "GXN", "device_class": "2", "state": "MD", "country": "US", "review_days": 267, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253116", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253050", "pathway": "510(k)", "company": "Informai", "parent": "Informai", "device": "RadOncAI", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-09-22", "product_code": "MUJ", "device_class": "2", "state": "TX", "country": "US", "review_days": 269, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253050", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K251232", "pathway": "510(k)", "company": "Megagen Implant Co., Ltd.", "parent": "Megagen Implant Co., Ltd.", "device": "MegaGen Zygoma Dental Implant System", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-04-22", "product_code": "DZE", "device_class": "2", "state": "", "country": "KR", "review_days": 422, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251232", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253058", "pathway": "510(k)", "company": "Shantou Institute of Ultrasonic Instruments Co., Ltd.", "parent": "Shantou Institute of Ultrasonic Instruments Co., Ltd.", "device": "Portable DR Imaging System", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-09-22", "product_code": "IZL", "device_class": "2", "state": "", "country": "CN", "review_days": 269, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253058", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253521", "pathway": "510(k)", "company": "Ecm Therapeutics, Inc.", "parent": "Ecm Therapeutics, Inc.", "device": "Ecmt-100 Wmd", "category": "Other", "specialty": "Unknown", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-11-13", "product_code": "KGN", "device_class": "U", "state": "PA", "country": "US", "review_days": 217, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253521", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260178", "pathway": "510(k)", "company": "Shenzhen Konmed Technology Co., Ltd.", "parent": "Shenzhen Konmed Technology Co., Ltd.", "device": "Pelvic Muscle Trainer (KM510, KM516B)", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-01-21", "product_code": "KPI", "device_class": "2", "state": "", "country": "CN", "review_days": 148, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260178", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260280", "pathway": "510(k)", "company": "Hycor Biomedical", "parent": "Hycor Biomedical", "device": "NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg", "category": "Diagnostics", "specialty": "Immunology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-01-29", "product_code": "DHB", "device_class": "2", "state": "CA", "country": "US", "review_days": 140, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260280", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260820", "pathway": "510(k)", "company": "Vieworks Co., Ltd.", "parent": "Vieworks Co., Ltd.", "device": "Vivix-S 4386W (Fxrd-4386Wa)", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-03-13", "product_code": "MQB", "device_class": "2", "state": "", "country": "KR", "review_days": 97, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260820", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260636", "pathway": "510(k)", "company": "Stryker Sustainability Solutions", "parent": "Stryker", "device": "Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-02-26", "product_code": "GEI", "device_class": "2", "state": "AZ", "country": "US", "review_days": 112, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260636", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254254", "pathway": "510(k)", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "parent": "Shenzhen Root Innovation Technology Co., Ltd.", "device": "Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-12-29", "product_code": "HGX", "device_class": "2", "state": "", "country": "CN", "review_days": 171, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254254", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253126", "pathway": "510(k)", "company": "Shenzhen Ziqing Medical Equipment Co., Ltd.", "parent": "Shenzhen Ziqing Medical Equipment Co., Ltd.", "device": "Wrist Blood Pressure Monitor (XW-05)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-09-25", "product_code": "DXN", "device_class": "2", "state": "", "country": "CN", "review_days": 266, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253126", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260729", "pathway": "510(k)", "company": "GuideAI Health", "parent": "GuideAI Health", "device": "Vascular Assist Occlusion Triage (VAOT) (v1.0)", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-03-06", "product_code": "QAS", "device_class": "2", "state": "MA", "country": "US", "review_days": 104, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260729", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253776", "pathway": "510(k)", "company": "W&H Dentalwerk Buermoos GmbH", "parent": "W&H Dentalwerk Buermoos GmbH", "device": "Implantmed Plus II & Piezomed Plus II Module", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-06-18", "date_received": "2025-11-26", "product_code": "DZI", "device_class": "2", "state": "", "country": "AT", "review_days": 204, "source_url": 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Dental Devices , Ltd.", "parent": "A.B. 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Manufacturer/Sterilizer/Packager/Supplier", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220003", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P210007/S014", "pathway": "PMA Supplement", "company": "Mobia Medical, Inc.", "parent": "Mobia Medical, Inc.", "device": "Vivistim Pair VNS System", "category": "Physical Medicine", "specialty": "Physical Medicine", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-05-22", "product_code": "QPY", "device_class": "3", "state": "TX", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210007", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P200045/S024", "pathway": "PMA Supplement", "company": "Bolton Medical, Inc.", "parent": "Bolton Medical, Inc.", "device": "RelayPro Thoracic Stent-Graft System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-05-20", "product_code": "MIH", "device_class": "3", "state": "FL", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200045", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P250013/S002", "pathway": "PMA Supplement", "company": "LivaNova USA, Inc.", "parent": "LivaNova USA, Inc.", "device": "aura6000\u0099 system", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Approved", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-05-19", "product_code": "MNQ", "device_class": "3", "state": "TX", "country": "US", "supplement_reason": "Postapproval Study Protocol", "review_days": 30, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250013", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P190015/S030", "pathway": "PMA Supplement", "company": "Bolton Medical, Inc.", "parent": "Bolton Medical, Inc.", "device": "TREO\u00ae Abdominal Stent-Graft System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-18", "date_received": "2026-05-20", "product_code": "MIH", "device_class": "3", "state": "FL", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190015", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P220016", "pathway": "PMA", "company": "Hepquant, LLC", "parent": "Hepquant, LLC", "device": "HepQuant SHUNT\u00ae Liver Diagnostic Test", "category": "Diagnostics", "specialty": "Clinical Chemistry", "status": "Approved", "cleared": true, "decision_date": "2026-06-18", "date_received": "2022-09-14", "product_code": "SIO", "device_class": "3", "state": "CO", "country": "US", "supplement_reason": "", "review_days": 1373, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220016", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261570", "pathway": "510(k)", "company": "Cynosure, LLC", "parent": "Cynosure, LLC", "device": "Picosure Workstation", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-05-12", "product_code": "GEX", "device_class": "2", "state": "MA", "country": "US", "review_days": 36, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261570", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260006", "pathway": "510(k)", "company": "Inosys, Inc.", "parent": "Inosys, Inc.", "device": "INOSS System", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-01-02", "product_code": "DZE", "device_class": "2", "state": "NY", "country": "US", "review_days": 166, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260006", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260867", "pathway": "510(k)", "company": "Hartalega NGC Sdn. Bhd.", "parent": "Hartalega NGC Sdn. Bhd.", "device": "Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)", "category": "General Hospital", "specialty": "General Hospital", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-03-17", "product_code": "LZA", "device_class": "1", "state": "", "country": "MY", "review_days": 92, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260867", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261544", "pathway": "510(k)", "company": "Stryker Instruments", "parent": "Stryker", "device": "Hydro Irrigation System", "category": "Other", "specialty": "Ear, Nose, Throat", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-05-08", "product_code": "EOB", "device_class": "2", "state": "MI", "country": "US", "review_days": 40, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261544", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260538", "pathway": "510(k)", "company": "Shenzhen Root Innovation Technology Co., Ltd.", "parent": "Shenzhen Root Innovation Technology Co., Ltd.", "device": "Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-02-17", "product_code": "HGX", "device_class": "2", "state": "", "country": "CN", "review_days": 120, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260538", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253055", "pathway": "510(k)", "company": "Nordic Kinetics AB", "parent": "Nordic Kinetics AB", "device": "Sine Monitoring Parkinson\u0092s Disease Tremor Dyskinesia Apple Watch (\u0093SMPDTDAW\u0094)", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2025-09-22", "product_code": "GYD", "device_class": "2", "state": "", "country": "SE", "review_days": 268, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253055", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260916", "pathway": "510(k)", "company": "Portal Access, Inc.", "parent": "Portal Access, Inc.", "device": "FLEXI-PORT\u0099 Power Injectable Implantable Port", "category": "General Hospital", "specialty": "General Hospital", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-03-19", "product_code": "LJT", "device_class": "2", "state": "FL", "country": "US", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260916", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261672", "pathway": "510(k)", "company": "Deka Research and Development", "parent": "Deka Research and Development", "device": "twiist Automated Insulin Delivery (AID) System", "category": "Diagnostics", "specialty": "Clinical Chemistry", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-05-21", "product_code": "QFG", "device_class": "2", "state": "NH", "country": "US", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261672", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253045", "pathway": "510(k)", "company": "Socko Medical Co., Ltd.", "parent": "Socko Medical Co., Ltd.", "device": "\u0093Socko\u0094 Vimax Spinal Fixation System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2025-09-22", "product_code": "NKB", "device_class": "2", "state": "", "country": "TW", "review_days": 268, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253045", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253255", "pathway": "510(k)", "company": "Foshan Pingchuang Medical Technology Co., Ltd.", "parent": "Foshan Pingchuang Medical Technology Co., Ltd.", "device": "Non-Sterile Ultrasound Gel Sterile Ultrasound Gel", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2025-09-29", "product_code": "MUI", "device_class": "2", "state": "", "country": "CN", "review_days": 261, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253255", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253155", "pathway": "510(k)", "company": "Beijing Fule Science & Technology Development Co., Ltd.", "parent": "Beijing Fule Science & Technology Development Co., Ltd.", "device": "Fule Metallic Lockable Intramedullary Nail Systems", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2025-09-26", "product_code": "HSB", "device_class": "2", "state": "", "country": "CN", "review_days": 264, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253155", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261631", "pathway": "510(k)", "company": "Abbott Medical", "parent": "Abbott", "device": "Amplatzer TorqVue Exchange System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-05-18", "product_code": "DQY", "device_class": "2", "state": "MN", "country": "US", "review_days": 30, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261631", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261638", "pathway": "510(k)", "company": "Oneness Biotech Co., Ltd.", "parent": "Oneness Biotech Co., Ltd.", "device": "Bonvadis\u00ae", "category": "Other", "specialty": "Unknown", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-05-18", "product_code": "FRO", "device_class": "U", "state": "", "country": "TW", "review_days": 30, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261638", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253634", "pathway": "510(k)", "company": "Hologic, Inc.", "parent": "Hologic", "device": "CoolSeal Generator\u00ae (CSL-200-90)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2025-11-19", "product_code": "GEI", "device_class": "2", "state": "MA", "country": "US", "review_days": 210, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253634", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260428", "pathway": "510(k)", "company": "Boston Scientific Corporation", "parent": "Boston Scientific", "device": "RIVOS\u0099 EUS Access Device (M00553900)", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-17", "date_received": "2026-02-10", "product_code": "ODG", "device_class": "2", "state": "MA", "country": "US", "review_days": 127, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260428", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252399", "pathway": "510(k)", "company": "Honsun (Nantong) Co., Ltd.", "parent": "Honsun (Nantong) Co., Ltd.", "device": "Portable Oxygen Concentrator", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": 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"company": "Abiomed, Inc.", "parent": "Abiomed, Inc.", "device": "Impella CP with SmartAssist", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-06-15", "date_received": "2026-05-18", "product_code": "OZD", "device_class": "3", "state": "MA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261604", "pathway": "510(k)", "company": "Neuroelectrics Barcelona S.L.U.", "parent": "Neuroelectrics Barcelona S.L.U.", "device": "Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-13", "date_received": "2026-05-14", "product_code": "GWQ", "device_class": "2", 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System", "category": "Diagnostics", "specialty": "Clinical Chemistry", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-09-22", "product_code": "MMI", "device_class": "2", "state": "NJ", "country": "US", "review_days": 262, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253051", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260849", "pathway": "510(k)", "company": "Rehasense USA, Inc.", "parent": "Rehasense USA, Inc.", "device": "Icon 35; Icon 45; Icon 60; Icon 30Faf", "category": "Physical Medicine", "specialty": "Physical Medicine", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-03-16", "product_code": "IOR", "device_class": "1", "state": "IL", "country": "US", "review_days": 87, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260849", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261610", "pathway": "510(k)", "company": "Instylla, Inc.", "parent": "Instylla, Inc.", "device": "Verge\u0099 Microcatheter", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-14", "product_code": "KRA", "device_class": "2", "state": "MA", "country": "US", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261610", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261209", "pathway": "510(k)", "company": "SurGenTec, LLC", "parent": "SurGenTec, LLC", "device": "Ion-L", "category": "Other", "specialty": "Unknown", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-04-13", "product_code": "MRW", "device_class": "U", "state": "FL", "country": "US", "review_days": 59, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261209", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260174", "pathway": "510(k)", "company": "Hitachi High-Tech Corp.", "parent": "Hitachi High-Tech Corp.", "device": "Probeat-Cr", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-01-21", "product_code": "LHN", "device_class": "2", "state": "", "country": "JP", "review_days": 141, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260174", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254145", "pathway": "510(k)", "company": "Smart Denture Conversions, LLC", "parent": "Smart Denture Conversions, LLC", "device": "Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut\u0099)", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-12-22", "product_code": "NHA", "device_class": "2", "state": "NC", "country": "US", "review_days": 171, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254145", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K250129", "pathway": "510(k)", "company": "Avita Corporation", "parent": "Avita Corporation", "device": "AViTA Breast Pump", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-01-17", "product_code": "HGX", "device_class": "2", "state": "", "country": "TW", "review_days": 510, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250129", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K250839", "pathway": "510(k)", "company": "Changzhou Boen Zhongding Medical Technology Co., Ltd.", "parent": "Changzhou Boen Zhongding Medical Technology Co., Ltd.", "device": "Dental X-ray System", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-03-20", "product_code": "OAS", "device_class": "2", "state": "", "country": "CN", "review_days": 448, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250839", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261256", "pathway": "510(k)", "company": "Shenzhen Magnet Technology Co., Ltd.", "parent": "Shenzhen Magnet Technology Co., Ltd.", "device": "Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)", "category": "Other", "specialty": "Ear, Nose, Throat", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-04-16", "product_code": "LXB", "device_class": "2", "state": "", "country": "CN", "review_days": 56, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261256", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254087", "pathway": "510(k)", "company": "Synthes (USA) Products, LLC", "parent": "Synthes (USA) Products, LLC", "device": "MAXFRAME AUTOSTRUT\u0099 with Bluetooth Multi-Axial Correction System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-12-18", "product_code": "KTT", "device_class": "2", "state": "PA", "country": "US", "review_days": 175, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254087", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261292", "pathway": "510(k)", "company": "PR Personal Care Laboratories", "parent": "PR Personal Care Laboratories", "device": "PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-04-20", "product_code": "NUC", "device_class": "2", "state": "CA", "country": "US", "review_days": 52, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261292", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260322", "pathway": "510(k)", "company": "Mighty Oak Medical", "parent": "Mighty Oak Medical", "device": "Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-01-30", "product_code": "QIH", "device_class": "2", "state": "CO", "country": "US", "review_days": 132, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260322", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253650", "pathway": "510(k)", "company": "Nuralogix Corporation", "parent": "Nuralogix Corporation", "device": "Anura Mobile Core SDK (M1)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-11-20", "product_code": "QME", "device_class": "2", "state": "", "country": "CA", "review_days": 203, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253650", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260859", "pathway": "510(k)", "company": "Hass Corp.", "parent": "Hass Corp.", "device": "Rosetta SM, Rosetta SP", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-03-16", "product_code": "EIH", "device_class": "2", "state": "", "country": "KR", "review_days": 87, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260859", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260653", "pathway": "510(k)", "company": "Distalmotion SA", "parent": "Distalmotion SA", "device": "Dexter L6 System", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-02-27", "product_code": "SDD", "device_class": "2", "state": "", "country": "CH", "review_days": 104, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260653", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P150035/S039", "pathway": "PMA Supplement", "company": "Abbott Medical", "parent": "Abbott", "device": "The AVEIR Leadless Pacemaker (LP)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-13", "product_code": "PNJ", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Postapproval Study Protocol", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150035", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P960030/S084", "pathway": "PMA Supplement", "company": "Abbott Medical", "parent": "Abbott", "device": "UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-06", "product_code": "NVN", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 36, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960030", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P110033/S099", "pathway": "PMA Supplement", "company": "Allergan", "parent": "Allergan", "device": "SKINVIVE by JUVEDERM\u00ae", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Approved", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-05-13", "product_code": "LMH", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename", "review_days": 394, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110033", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P960013/S133", "pathway": "PMA Supplement", "company": "Abbott Medical", "parent": "Abbott", "device": "UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-06", "product_code": "NVN", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 36, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960013", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P170030/S058", "pathway": "PMA Supplement", "company": "Biotronik AG", "parent": "Biotronik AG", "device": "Orsiro Mission Sirolimus Eluting Coronary Stent System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-06-11", "date_received": "2025-06-13", "product_code": "NIQ", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 363, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P240023/S005", "pathway": "PMA Supplement", "company": "Merit Medical Systems, Inc.", "parent": "Merit Medical", "device": "WRAPSODY\u00ae Cell-Impermeable Endoprosthesis", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-13", "product_code": "PFV", "device_class": "3", "state": "UT", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240023", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P980035/S841", "pathway": "PMA Supplement", "company": "Medtronic, Inc.", "parent": "Medtronic", "device": "Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADVDD01, SED01, SEDR01, SES01); Adapta, Versa, Sensia IPG (SE", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-20", "product_code": "NVZ", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 22, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980035", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P810002/S126", "pathway": "PMA Supplement", "company": "Abbott Medical", "parent": "Abbott", "device": "Masters Series\u0099 Aortic Valved Graft with Hemashield\u0099 Graft Technology (CAVGJ)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-06-11", "date_received": "2026-05-13", "product_code": "LWQ", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P810002", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253192", "pathway": "510(k)", "company": "Alpha Intelligence Manifolds, Inc.", "parent": "Alpha Intelligence Manifolds, Inc.", "device": "DeepXray Spina", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2025-09-26", "product_code": "SAO", "device_class": "2", "state": "", "country": "TW", "review_days": 257, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253192", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253115", "pathway": "510(k)", "company": "Movmedix S.A.S.", "parent": "Movmedix S.A.S.", "device": "Lars Acj", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2025-09-24", "product_code": "HTN", "device_class": "2", "state": "", "country": "FR", "review_days": 259, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253115", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260614", "pathway": "510(k)", "company": "Sivantos GmbH", "parent": "Sivantos GmbH", "device": "Tinnitus Therapy", "category": "Other", "specialty": "Ear, Nose, Throat", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2026-02-25", "product_code": "KLW", "device_class": "2", "state": "", "country": "DE", "review_days": 105, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260614", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261016", "pathway": "510(k)", "company": "Medacta International, SA", "parent": "Medacta International, SA", "device": "MSS - Humeral reverse liners extension", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2026-03-27", "product_code": "PHX", "device_class": "2", "state": "", "country": "CH", "review_days": 75, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261016", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254121", "pathway": "510(k)", "company": "DNA Genotek, Inc.", "parent": "DNA Genotek, Inc.", "device": "Colli-Pee\u0095Dx Urine Collection Kit", "category": "Diagnostics", "specialty": "Microbiology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2025-12-19", "product_code": "SIH", "device_class": "2", "state": "", "country": "CA", "review_days": 173, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254121", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261329", "pathway": "510(k)", "company": "Centerline Biomedical", "parent": "Centerline Biomedical", "device": "Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2026-04-22", "product_code": "DQK", "device_class": "2", "state": "OH", "country": "US", "review_days": 49, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261329", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260810", "pathway": "510(k)", "company": "Tyber Medical, LLC", "parent": "Tyber Medical, LLC", "device": "Anteralign LS coverplate", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2026-03-12", "product_code": "OVD", "device_class": "2", "state": "PA", "country": "US", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260810", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260414", "pathway": "510(k)", "company": "Tech-Image CO., LTD.", "parent": "Tech-Image CO., LTD.", "device": "\u0093Tech-Image\u0094 Video Endoscope System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": "2026-02-09", "product_code": "GCJ", "device_class": "2", "state": "", "country": "TW", "review_days": 121, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260414", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261174", "pathway": "510(k)", "company": "Rxsight, Inc.", "parent": "Rxsight, Inc.", "device": "RxSight\u00ae Insertion Device", "category": "Ophthalmic", "specialty": "Ophthalmic", "status": "Cleared", "cleared": true, "decision_date": "2026-06-10", "date_received": 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"device_class": "2", "state": "", "country": "IE", "review_days": 151, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254137", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253569", "pathway": "510(k)", "company": "Atmo Biosciences, Ltd.", "parent": "Atmo Biosciences, Ltd.", "device": "Atmo Gas Capsule System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2025-11-17", "product_code": "NYV", "device_class": "2", "state": "", "country": "AU", "review_days": 186, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253569", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260329", "pathway": "510(k)", "company": "SurGenTec, LLC", "parent": "SurGenTec, LLC", "device": "Ion-C Navigation Instruments", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-01-30", "product_code": "OLO", "device_class": "2", "state": "FL", "country": "US", "review_days": 112, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260329", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253773", "pathway": "510(k)", "company": "Taizhou Huangyan Guanhong Plastic Steel Products Factory", "parent": "Taizhou Huangyan Guanhong Plastic Steel Products Factory", "device": "Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong", "category": "General Hospital", "specialty": "General Hospital", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2025-11-26", "product_code": "MMK", "device_class": "2", "state": "", "country": "CN", "review_days": 177, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253773", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261280", "pathway": "510(k)", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "parent": "Vivachek Biotech (Hangzhou) Co., Ltd.", "device": "BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel", "category": "Other", "specialty": "Clinical Toxicology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-17", "product_code": "NFT", "device_class": "2", "state": "", "country": "CN", "review_days": 35, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261280", "first_seen": 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"device_class": "1", "state": "", "country": "TH", "review_days": 242, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253060", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252915", "pathway": "510(k)", "company": "Ai Health Highway India Pvt., Ltd.", "parent": "Ai Health Highway India Pvt., Ltd.", "device": "AiSteth\u00ae", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2025-09-12", "product_code": "DQD", "device_class": "2", "state": "", "country": "IN", "review_days": 252, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252915", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253949", "pathway": "510(k)", "company": "CHISON Medical Technologies Co., Ltd.", "parent": "CHISON Medical Technologies Co., Ltd.", "device": "SonoPort Series Digital Color Doppler Ultrasound System 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"category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-02-19", "product_code": "OBP", "device_class": "2", "state": "", "country": "DE", "review_days": 92, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260560", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260695", "pathway": "510(k)", "company": "Intuitive Surgical", "parent": "Intuitive Surgical", "device": "da Vinci Firefly Imaging System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-03-03", "product_code": "NAY", "device_class": "2", "state": "CA", "country": "US", "review_days": 80, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260695", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P840001/S627", "pathway": "PMA Supplement", "company": "Medtronic Neuromodulation", "parent": "Medtronic", "device": "Master Restore\u0099; Itrel\u0099; Synergy\u0099; Intellis\u0099; Vanta\u0099 and Inceptiv\u0099 Spinal Cord Stimulation Systems and Pisces\u0099; Specify\u0099", "category": "Neurology", "specialty": "Neurology", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-24", "product_code": "LGW", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P110019/S141", "pathway": "PMA Supplement", "company": "Abbott Vascular", "parent": "Abbott", "device": "XIENCE Alpine\u0099, XIENCE Sierra\u0099, XIENCE PRO\u0099 S, and XIENCE Skypoint\u0099 Everolimus Eluting Coronary Stent Systems", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-23", "product_code": "NIQ", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110019", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P080025/S345", "pathway": "PMA Supplement", "company": "Medtronic Neuromodulation", "parent": "Medtronic", "device": "InterStim\u0099 Therapy System; Verify\u0099 Evaluation System (3550-05, 3560031, 3889, 978A1, 978B1)", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-24", "product_code": "QON", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P960009/S535", "pathway": "PMA Supplement", "company": "Medtronic, Inc.", "parent": "Medtronic", "device": "Activa\u0099 Deep Brain Stimulation Therapy System; Percept\u0099 PC BrainSense\u0099 (3387S, 3389S, 3550-05, B31010)", "category": "Neurology", "specialty": "Neurology", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-24", "product_code": "MHY", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P110008/S015", "pathway": "PMA Supplement", "company": "Companion Spine France", "parent": "Companion Spine France", "device": "coflex\u00ae Interlaminar Technology", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Approved", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-24", "product_code": "NQO", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Postapproval Study Protocol", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110008", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P840001/S626", "pathway": "PMA Supplement", "company": "Medtronic Neuromodulation", "parent": "Medtronic", "device": "Master Restore\u0099, Itrel\u0099, Synergy Intellis\u0099, Vanta\u0099 and Inceptiv\u0099 Spinal Cord Stimulation Systems and Pisces\u0099, Specify\u0099", "category": "Neurology", "specialty": "Neurology", "status": "Approved (30-day notice)", "cleared": 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"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P230036/S018", "pathway": "PMA Supplement", "company": "Abbott Medical", "parent": "Abbott", "device": "Esprit\u0099 BTK Everolimus Eluting Resorbable Scaffold System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-23", "product_code": "NXW", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230036", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P960043/S134", "pathway": "PMA Supplement", "company": "Abbott Vascular, Inc.", "parent": "Abbott", "device": "Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-22", "date_received": "2026-04-24", "product_code": "MGB", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960043", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K251920", "pathway": "510(k)", "company": "Dcstar, Inc.", "parent": "Dcstar, Inc.", "device": "Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-06-23", "product_code": "BZD", "device_class": "2", "state": "NY", "country": "US", "review_days": 332, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251920", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261325", "pathway": "510(k)", "company": "Shenzhen Ulike Smart Electronics Co., Ltd.", "parent": "Shenzhen Ulike Smart Electronics Co., Ltd.", "device": "Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-22", "product_code": "OHT", "device_class": "2", "state": "", "country": "CN", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261325", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261291", "pathway": "510(k)", "company": "Cork Medical", "parent": "Cork Medical", "device": "Nisus NPWT Canister 500-mL (CPC-500)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-20", "product_code": "OMP", "device_class": "2", "state": "IN", "country": "US", "review_days": 31, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261291", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254131", "pathway": "510(k)", "company": "DeepHealth, Inc.", "parent": "DeepHealth, Inc.", "device": "BAC", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-12-22", "product_code": "QIH", "device_class": "2", "state": "MA", "country": "US", "review_days": 150, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254131", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253112", "pathway": "510(k)", "company": "Hlb Lifescience Co., Ltd.", "parent": "Hlb Lifescience Co., Ltd.", "device": "Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)", "category": "General Hospital", "specialty": "General Hospital", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-09-24", "product_code": "FMF", "device_class": "2", "state": "", "country": "KR", "review_days": 239, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253112", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253191", "pathway": "510(k)", "company": "Dental Creativ Management GmbH", "parent": "Dental Creativ Management GmbH", "device": "DCMhotbond zircon", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-09-26", "product_code": "EIH", "device_class": "2", "state": "", "country": "DE", "review_days": 237, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253191", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253245", "pathway": "510(k)", "company": "Boston Aesthetics, Inc.", "parent": "Boston Aesthetics, Inc.", "device": "Boston 2910 (Boston 2910)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-09-29", "product_code": "GEX", "device_class": "2", "state": "DE", "country": "US", "review_days": 234, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253245", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260618", "pathway": "510(k)", "company": "Ulthera, Inc.", "parent": "Ulthera, Inc.", "device": "Ulthera\u00ae System", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-25", "product_code": "OHV", "device_class": "2", "state": "NC", "country": "US", "review_days": 85, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260618", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260580", "pathway": "510(k)", "company": "Olympus Medical Systems Corp.", "parent": "Olympus", "device": "Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-20", "product_code": "PKL", "device_class": "2", "state": "", "country": "JP", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260580", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253816", "pathway": 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(WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-27", "product_code": "FAJ", "device_class": "2", "state": "", "country": "DE", "review_days": 83, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260649", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260066", "pathway": "510(k)", "company": "PanopticAI Technologies Limited", "parent": "PanopticAI Technologies Limited", "device": "PanopticAI Vital Signs (1.6.1-22)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-01-09", "product_code": "QME", "device_class": "2", "state": "", "country": "HK", "review_days": 132, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260066", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253352", "pathway": "510(k)", "company": "Pegavision Corporation", "parent": "Pegavision Corporation", "device": "Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses", "category": "Ophthalmic", "specialty": "Ophthalmic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-09-30", "product_code": "LPL", "device_class": "2", "state": "", "country": "TW", "review_days": 233, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253352", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260068", "pathway": "510(k)", "company": "Pjur Group Luxembourg S.A.", "parent": "Pjur Group Luxembourg S.A.", "device": "pjur NATURE Touch, 100 ml", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-01-09", "product_code": "NUC", "device_class": "2", "state": "", "country": "LU", "review_days": 132, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260068", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261315", "pathway": "510(k)", "company": "Siemens Medical Solutions USA, Inc.", "parent": "Siemens Medical Solutions USA, Inc.", "device": "Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-21", "product_code": "KPS", "device_class": "2", "state": "TN", "country": "US", "review_days": 30, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261315", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260582", "pathway": "510(k)", "company": "Orthosoft Inc. (d/b/a) Zimmer CAS", "parent": "Orthosoft Inc. (d/b/a) Zimmer CAS", "device": "ROSA\u00ae Shoulder System", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-20", "product_code": "OLO", "device_class": "2", "state": "", "country": "CA", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260582", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260962", "pathway": "510(k)", "company": "Taewoong Medical Co., Ltd.", "parent": "Taewoong Medical Co., Ltd.", "device": "Sphincterotome", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-03-23", "product_code": "KNS", "device_class": "2", "state": "", "country": "KR", "review_days": 59, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260962", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254244", "pathway": "510(k)", "company": "Shenzhen TPH Technology Co., Ltd.", "parent": "Shenzhen TPH Technology Co., Ltd.", "device": "Wearable Breast Pump (Model S39)", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-12-29", "product_code": "HGX", "device_class": "2", "state": "", "country": "CN", "review_days": 143, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254244", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261359", "pathway": "510(k)", "company": "Dexcom, Inc.", "parent": "Dexcom", "device": "Stelo Glucose Biosensor System", "category": "Diagnostics", "specialty": "Clinical Chemistry", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-24", "product_code": "SAF", "device_class": "2", "state": "CA", "country": "US", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261359", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "DEN250028", "pathway": "De Novo", "company": "Spectralmd, Inc.", "parent": "Spectralmd, Inc.", "device": "DeepView AI\u00ae System", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Granted", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-06-27", "product_code": "SHY", "device_class": "2", "state": "TX", "country": "US", "review_days": 328, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN250028", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252746", "pathway": "510(k)", "company": "Dr\u00e4gerwerk AG Co. Kgaa", "parent": "Dr\u00e4gerwerk AG Co. Kgaa", "device": "Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-08-29", "product_code": "BSZ", "device_class": "2", "state": "", "country": "DE", "review_days": 265, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252746", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260234", "pathway": "510(k)", "company": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "parent": "Smart Alfa Teknoloji San. Ve Tic. A.S.", "device": "MSK Go", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-01-26", "product_code": "QIH", "device_class": "2", "state": "", "country": "TR", "review_days": 115, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260234", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254141", "pathway": "510(k)", "company": "Guangdong Dayang Medical Technology Co., Ltd.", "parent": "Guangdong Dayang Medical Technology Co., Ltd.", "device": "Manual Wheelchair (DY01903(2))", "category": "Physical Medicine", "specialty": "Physical Medicine", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-12-22", "product_code": "IOR", "device_class": "1", "state": "", "country": "CN", "review_days": 150, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254141", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253956", "pathway": "510(k)", "company": "Sofradim Production", "parent": "Sofradim Production", "device": "ProGrip\u0099 advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-12-10", "product_code": "FTL", "device_class": "2", "state": "", "country": "FR", "review_days": 162, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253956", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253720", "pathway": "510(k)", "company": "Wuhan United Imaging Healthcare Co.,Ltd", "parent": "Wuhan United Imaging Healthcare Co.,Ltd", "device": "uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite", "category": "Imaging", "specialty": "Radiology", "status": 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"pathway": "PMA Supplement", "company": "Boston Scientific Corp", "parent": "Boston Scientific", "device": "Celestia Implantable Pulse Generator, Celestia External Trial Stimulator", "category": "Neurology", "specialty": "Neurology", "status": "Approved", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-09", "product_code": "LGW", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 101, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030017", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P200035/S033", "pathway": "PMA Supplement", "company": "Organox Limited", "parent": "Organox Limited", "device": "OrganOx metra\u00ae System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Approved", "cleared": true, "decision_date": "2026-05-21", "date_received": "2025-12-30", "product_code": "QQK", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 142, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200035", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P180028/S019", "pathway": "PMA Supplement", "company": "Philips Medical Systems", "parent": "Philips", "device": "HeartStart FRx Defibrillator (861304)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-25", "product_code": "MKJ", "device_class": "3", "state": "WA", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 85, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180028", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P230009/S016", "pathway": "PMA Supplement", "company": "Guardant Health, Inc.", "parent": "Guardant Health, Inc.", "device": "Shield", "category": "Other", "specialty": "Medical Genetics", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-05-01", "product_code": "PHP", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 20, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230009", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P140010/S104", "pathway": "PMA Supplement", "company": "Medtronic, Inc.", "parent": "Medtronic", "device": "IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-23", "product_code": "ONU", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140010", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P180001/S017", "pathway": "PMA Supplement", "company": "William Cook Europe Aps", "parent": "William Cook Europe Aps", "device": "Zenith Fenestrated AAA Endovascular Graft", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-23", "product_code": "MIH", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180001", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P140016/S017", "pathway": "PMA Supplement", "company": "Cook Medical Incorporated", "parent": "Cook Medical", "device": "Zenith Alpha Thoracic Endovascular Graft; Zenith Dissection Endovascular System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-23", "product_code": "MIH", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140016", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P160028/S007", "pathway": "PMA Supplement", "company": "Philips Medical Systems, Inc.", "parent": "Philips", "device": "HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-02-25", "product_code": "MKJ", "device_class": "3", "state": "WA", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 85, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160028", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P190008/S049", "pathway": "PMA Supplement", "company": "Medtronic Vascular, Inc.", "parent": "Medtronic", "device": "IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-23", "product_code": "PRC", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190008", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P020018/S068", "pathway": "PMA Supplement", "company": "Cook, Inc.", "parent": "Cook, Inc.", "device": "Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular Graft", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-21", "date_received": "2026-04-23", "product_code": "MIH", "device_class": "3", "state": "IN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020018", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260594", "pathway": "510(k)", "company": "Shenzhen Xiazhifeng Electronic Co., Ltd.", "parent": "Shenzhen Xiazhifeng Electronic Co., Ltd.", "device": "IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-02-23", "product_code": "OHT", "device_class": "2", "state": "", "country": "CN", "review_days": 86, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260594", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260304", "pathway": "510(k)", "company": "WAVE Medical AG", "parent": "WAVE Medical AG", "device": "WAVE PTA Balloon Catheter", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-01-30", "product_code": "LIT", "device_class": "2", "state": "", "country": "CH", "review_days": 110, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260304", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253596", "pathway": "510(k)", "company": "Canon Medical Systems Corporation", "parent": "Canon Medical", "device": "Aquilion ONE (TSX-308A/TSX-306A) V2.0", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-11-18", "product_code": "JAK", "device_class": "2", "state": "", "country": "JP", "review_days": 183, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253596", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253911", "pathway": "510(k)", "company": "Neko Health AB", "parent": "Neko Health AB", "device": "Derma-2", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-12-08", "product_code": "LHQ", "device_class": "1", "state": "", "country": "SE", "review_days": 163, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253911", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253570", "pathway": "510(k)", "company": "Shenzhen Jamr Technology Co., Ltd.", "parent": "Shenzhen Jamr Technology Co., Ltd.", "device": "Blood Pressure Monitor (W06LT)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-11-17", "product_code": "DXN", "device_class": "2", "state": "", "country": "CN", "review_days": 184, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253570", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252717", "pathway": "510(k)", "company": "Varian Medical Systems", "parent": "Varian Medical Systems", "device": "MAASTRO Rectal Applicator Set", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-08-28", "product_code": "JAQ", "device_class": "2", "state": "CA", "country": "US", "review_days": 265, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252717", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260351", "pathway": "510(k)", "company": "MicroPort NeuroTech (Shanghai) Co., Ltd.", "parent": "MicroPort NeuroTech (Shanghai) Co., Ltd.", "device": "Numen\u0099 Helia Coil Embolization System; NumenFR\u0099 Detachment System", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-02-03", "product_code": "HCG", "device_class": "2", "state": "", "country": "CN", "review_days": 106, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260351", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253134", "pathway": "510(k)", "company": "Lagis Enterprise Co., Ltd.", "parent": "Lagis Enterprise Co., Ltd.", "device": "LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-09-25", "product_code": "GEI", "device_class": "2", "state": "", "country": "TW", "review_days": 237, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253134", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253774", "pathway": "510(k)", "company": "Elos Medtech Pinol A/S", "parent": "Elos Medtech Pinol A/S", "device": "Elos Accurate\u00ae Denture Fixation System", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-11-26", "product_code": "NHA", "device_class": "2", "state": "", "country": "DK", "review_days": 175, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253774", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260717", "pathway": "510(k)", "company": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.", "parent": "Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.", "device": "Mobility Scooter (Air Carbon)", "category": "Physical Medicine", "specialty": "Physical Medicine", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-03-05", "product_code": "INI", "device_class": "2", "state": "", "country": "CN", "review_days": 76, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260717", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260098", "pathway": "510(k)", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "parent": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "device": "ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-01-13", "product_code": "MHX", "device_class": "2", "state": "", "country": "CN", "review_days": 127, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260098", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252707", "pathway": "510(k)", "company": "Suzhou Zenith Vascular SciTech Limited", "parent": "Suzhou Zenith Vascular SciTech Limited", "device": "Zenith Aspiration Catheter; Disposable Aspiration Tubing Set", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2025-08-27", "product_code": "NRY", "device_class": "2", "state": "", "country": "CN", "review_days": 266, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252707", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261286", "pathway": "510(k)", "company": "Circadia Health, Inc.", "parent": "Circadia Health, Inc.", "device": "The Circadia C300 System (C300)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-04-20", "product_code": "DRT", "device_class": "2", "state": "CA", "country": "US", "review_days": 30, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261286", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P960009/S531", "pathway": "PMA Supplement", "company": "Medtronic, Inc.", "parent": "Medtronic", "device": "Activa\u0099 Deep Brain Stimulation Therapy System, Percept\u0099 PC BrainSense\u0099", "category": "Neurology", "specialty": "Neurology", "status": "Approved", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-02-19", "product_code": "MHY", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P150040/S025", "pathway": "PMA Supplement", "company": "Carl Zeiss Meditec, Inc.", "parent": "Carl Zeiss Meditec, Inc.", "device": "Visumax Femtosecond Laser", "category": "Ophthalmic", "specialty": "Ophthalmic", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-04-21", "product_code": "OTL", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150040", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P160022/S052", "pathway": "PMA Supplement", "company": "ZOLL Medical Corporation", "parent": "ZOLL Medical Corporation", "device": "SurePower I; SurePower II", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-05-12", "product_code": "MKJ", "device_class": "3", "state": "MA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 8, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P250033/S001", "pathway": "PMA Supplement", "company": "Endospan , Ltd.", "parent": "Endospan , Ltd.", "device": "NEXUS\u00ae Aortic Arch Stent Graft System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-04-23", "product_code": "SDZ", "device_class": "3", "state": "WY", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250033", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P840001/S620", "pathway": "PMA Supplement", "company": "Medtronic Neuromodulation", "parent": "Medtronic", "device": "Master Restore\u0099, Itrel\u0099, Synergy\u0099, Intellis\u0099, Vanta\u0099 and Inceptiv\u0099 Spinal Cord Stimulation Systems and Pisces\u0099, Specify\u0099", "category": "Neurology", "specialty": "Neurology", "status": "Approved", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-02-19", "product_code": "LGW", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 90, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P230032/S005", "pathway": "PMA Supplement", "company": "AutoGenomics, Inc.", "parent": "AutoGenomics, Inc.", "device": "AvertD and AvertD Buccal Sample Collection Kit", "category": "Other", "specialty": "Clinical Toxicology", "status": "Approved", "cleared": true, "decision_date": "2026-05-20", "date_received": "2026-04-22", "product_code": "QZH", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Postapproval Study Protocol", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230032", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261299", "pathway": "510(k)", "company": "Pegavision Corporation", "parent": "Pegavision Corporation", "device": "Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses", "category": "Ophthalmic", "specialty": "Ophthalmic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2026-04-20", "product_code": "LPL", "device_class": "2", "state": "", "country": "TW", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261299", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252985", "pathway": "510(k)", "company": "Sejong Medical Co., Ltd.", "parent": "Sejong Medical Co., Ltd.", "device": "Laport", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2025-09-18", "product_code": "GCJ", "device_class": "2", "state": "", "country": "KR", "review_days": 243, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252985", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253722", "pathway": "510(k)", "company": "Luminex Corporation", "parent": "Luminex Corporation", "device": "LIAISON PLEX Gastrointestinal Flex Assay", "category": "Diagnostics", "specialty": "Microbiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2025-11-24", "product_code": "PCH", "device_class": "2", "state": "IL", "country": "US", "review_days": 176, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253722", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K251270", "pathway": "510(k)", "company": "Biomet, Inc.", "parent": "Biomet, Inc.", "device": "Taperloc\u00ae Complete Hip Stem", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2025-04-24", "product_code": "LPH", "device_class": "2", "state": "IN", "country": "US", "review_days": 390, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251270", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260577", "pathway": "510(k)", "company": "Maine Molecular Quality Controls, Inc.", "parent": "Maine Molecular Quality Controls, Inc.", "device": "FilmArray TF Control Panel M527", "category": "Diagnostics", "specialty": "Microbiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2026-02-20", "product_code": "PMN", "device_class": "2", "state": "ME", "country": "US", "review_days": 88, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260577", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253309", "pathway": "510(k)", "company": "Shenzhen Soga Technology Co., Ltd.", "parent": "Shenzhen Soga Technology Co., Ltd.", "device": "SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2025-09-29", "product_code": "NVK", "device_class": "2", "state": "", "country": "CN", "review_days": 232, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253309", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260146", "pathway": "510(k)", "company": "Orthofix Srl", "parent": "Orthofix Srl", "device": "Fitbone\u00ae Transport And Lengthening System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2026-01-20", "product_code": "HSB", "device_class": "2", "state": "", "country": "IT", "review_days": 119, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260146", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254024", "pathway": "510(k)", "company": "Multi Radiance Medical, Inc.", "parent": "Multi Radiance Medical, Inc.", "device": "MR5 Activ Pro", "category": "Physical Medicine", "specialty": "Physical Medicine", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2025-12-16", "product_code": "NHN", "device_class": "2", "state": "OH", "country": "US", "review_days": 154, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254024", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261071", "pathway": "510(k)", "company": "DiaDent Group International", "parent": "DiaDent Group International", "device": "DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2026-04-01", "product_code": "EBF", "device_class": "2", "state": "", "country": "KR", "review_days": 48, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261071", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260268", "pathway": "510(k)", "company": "Bernhard F\u00f6rster GmbH (Bernhard Foerster Ltd.)", "parent": "Bernhard F\u00f6rster GmbH (Bernhard Foerster Ltd.)", "device": "OrthoEasy Pal; OrthoEasy Pal Long Neck", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-19", "date_received": "2026-01-28", "product_code": "OAT", "device_class": "2", "state": "", "country": "DE", "review_days": 111, "source_url": 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"device": "Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-13", "date_received": "2026-04-17", "product_code": "NIQ", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 26, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160043", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260415", "pathway": "510(k)", "company": "Light Tree Ventures Europe B.V.", "parent": "Light Tree Ventures Europe B.V.", "device": "myLEDmask 2 (MJ-144)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-02-09", "product_code": "OHS", "device_class": "2", "state": "", "country": "NL", "review_days": 92, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260415", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254192", "pathway": "510(k)", "company": "Asensus Surgical", "parent": "Asensus Surgical", "device": "Senhance Ultrasonic System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-12-23", "product_code": "NAY", "device_class": "2", "state": "NC", "country": "US", "review_days": 140, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254192", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252731", "pathway": "510(k)", "company": "Promimic AB", "parent": "Promimic AB", "device": "Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-08-28", "product_code": "DZE", "device_class": "2", "state": "", "country": "SE", "review_days": 257, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252731", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260725", "pathway": "510(k)", "company": "Hindernis DE Mexico, S.A.P.I. DE C.V.", "parent": "Hindernis DE Mexico, S.A.P.I. DE C.V.", "device": "BA\u00dcMER Surgical Gowns (COP01, COP04, COP05, COP10)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-03-05", "product_code": "FYA", "device_class": "2", "state": "", "country": "MX", "review_days": 68, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260725", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260051", "pathway": "510(k)", "company": "CorVent\u00ae Medical, Inc.", "parent": "CorVent\u00ae Medical, Inc.", "device": "CorVision\u00ae (91-205-Z0014)", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-01-08", "product_code": "MOD", "device_class": "2", "state": "ND", "country": "US", "review_days": 124, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260051", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260235", "pathway": "510(k)", "company": "Datar Cancer Genetics Private Limited", "parent": "Datar Cancer Genetics Private Limited", "device": "CellDx-Tissue", "category": "Diagnostics", "specialty": "Pathology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-01-26", "product_code": "PZM", "device_class": "2", "state": "", "country": "IN", "review_days": 106, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260235", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261196", "pathway": "510(k)", "company": "Promisemed Hangzhou Meditech Co., Ltd.", "parent": "Promisemed Hangzhou Meditech Co., Ltd.", "device": "Promisemed VeriEcto Automatic Biopsy Needles", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-04-13", "product_code": "KNW", "device_class": "2", "state": "", "country": "CN", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261196", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260473", "pathway": "510(k)", "company": "Shenzhen Kingboom Technology Co., Ltd.", "parent": "Shenzhen Kingboom Technology Co., Ltd.", "device": "Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-02-12", "product_code": "BTA", "device_class": "2", "state": "", "country": "CN", "review_days": 89, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260473", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260378", "pathway": "510(k)", "company": "AZmed", "parent": "AZmed", "device": "Rayvolve", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-02-05", "product_code": "QBS", "device_class": "2", "state": "", "country": "FR", "review_days": 96, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260378", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260837", "pathway": "510(k)", "company": "Life Spine, Inc.", "parent": "Life Spine, Inc.", "device": "VersaLift Expandable System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-03-13", "product_code": "MAX", "device_class": "2", "state": "IL", "country": "US", "review_days": 60, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260837", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260850", "pathway": "510(k)", "company": "Osteomni, Inc.", "parent": "Osteomni, Inc.", "device": "Osteomni Spinal Cages System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-03-16", "product_code": "ODP", "device_class": "2", "state": "FL", "country": "US", "review_days": 57, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260850", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P020012/S052", "pathway": "PMA Supplement", "company": "Tiger Aesthetics Medical, LLC", "parent": "Tiger Aesthetics Medical, LLC", "device": "Bellafill\u00ae Dermal Filler", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-04-13", "product_code": "LMH", "device_class": "3", "state": "PA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 29, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020012", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P990075/S068", "pathway": "PMA Supplement", "company": "Mentor Worldwide, LLC", "parent": "Mentor Worldwide, LLC", "device": "MENTOR Saline-Filled and Spectrum\u0099 Breast Implants", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-04-06", "product_code": "FWM", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 36, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990075", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P170019/S067", "pathway": "PMA Supplement", "company": "Foundation Medicine, Inc.", "parent": "Foundation Medicine, Inc.", "device": "FoundationOne CDx", "category": "Diagnostics", "specialty": "Pathology", "status": "Approved", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-07-14", "product_code": "PQP", "device_class": "3", "state": "MA", "country": "US", "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename", "review_days": 302, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P170002/S050", "pathway": "PMA Supplement", "company": "Teoxane S.A.", "parent": "Teoxane S.A.", "device": "RHA Redensity\u00ae Eye Lido; RHA Redensity\u00ae Eye", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Approved", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-08-29", "product_code": "LMH", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 256, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170002", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P240020/S004", "pathway": "PMA Supplement", "company": "Keri Medical SA", "parent": "Keri Medical SA", "device": "TOUCH\u00ae CMC 1 Prosthesis", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Approved", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-11-21", "product_code": "SFA", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 172, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240020", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P010014/S116", "pathway": "PMA Supplement", "company": "Biomet Manufacturing Corp", "parent": "Biomet Manufacturing Corp", "device": "Oxford\u00ae Partial Knee System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-05-12", "date_received": "2026-04-17", "product_code": "NRA", "device_class": "3", "state": "IN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 25, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010014", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P100021/S132", "pathway": "PMA Supplement", "company": "Medtronic Vascular", "parent": "Medtronic", "device": "Endurant\u0099 II/IIs Stent Graft System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-05-12", "date_received": "2025-10-27", "product_code": "MIH", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Labeling Change - PAS", "review_days": 197, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100021", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252655", "pathway": "510(k)", "company": "Shenzhen Imdk Medical Technology Co., Ltd.", "parent": "Shenzhen Imdk Medical Technology Co., Ltd.", "device": "Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-08-22", "product_code": "DQA", "device_class": "2", "state": "", "country": "CN", "review_days": 262, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252655", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260805", "pathway": "510(k)", "company": "Vericom Co., Ltd.", "parent": "Vericom Co., Ltd.", "device": "Dual Core", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-03-12", "product_code": "EBF", "device_class": "2", "state": "", "country": "KR", "review_days": 60, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260805", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252880", "pathway": "510(k)", "company": "Pytheas Navigation Sas", "parent": "Pytheas Navigation Sas", "device": "Pytheas Your Guided Trajectory", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-09-10", "product_code": "OLO", "device_class": "2", "state": "", "country": "FR", "review_days": 243, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252880", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261214", "pathway": "510(k)", "company": "Speclipse, Inc.", "parent": "Speclipse, Inc.", "device": "Pico Shining (Pico-K; Picofy)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-04-14", "product_code": "GEX", "device_class": "2", "state": "", "country": "KR", "review_days": 27, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261214", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260196", "pathway": "510(k)", "company": "Ethicon Endo-Surgery, LLC", "parent": "Ethicon", "device": "ETHICON\u0099 Circular Stapler (CDH21mm); ETHICON\u0099 Circular Stapler (CDH25mm); ETHICON\u0099 Circular Stapler (CDH29mm); ETHICON\u0099 Circular Stapler (CDH33mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS21mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS25mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS29mm); ETHICON\u0099 Circular Stapler - XL Sealed (ECS33mm)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-01-22", "product_code": "GDW", "device_class": "2", "state": "PR", "country": "US", "review_days": 109, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260196", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K250964", "pathway": "510(k)", "company": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "parent": "Jiangsu Jumao X-Care Medical Equipment Co., Ltd.", "device": "Protable Phlegm Suction Unit (JMA D01)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-03-31", "product_code": "JCX", "device_class": "2", "state": "", "country": "CN", "review_days": 406, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250964", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253696", "pathway": "510(k)", "company": "Verathon Medical (Canada) Ulc", "parent": "Verathon Medical (Canada) Ulc", "device": "CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-11-21", "product_code": "FAJ", "device_class": "2", "state": "", "country": "CA", "review_days": 171, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253696", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254228", "pathway": "510(k)", "company": "Karl Storz SE & CO. KG", "parent": "Karl Storz", "device": "KARL STORZ Trocars with Valve Seals", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-12-26", "product_code": "GCJ", "device_class": "2", "state": "DE", "country": "US", "review_days": 136, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254228", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260842", "pathway": "510(k)", "company": "Hardy Diagnostics", "parent": "Hardy Diagnostics", "device": "HardyDisk AST Gepotidacin 10\u00b5g (GEP10)", "category": "Diagnostics", "specialty": "Microbiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-03-16", "product_code": "JTN", "device_class": "2", "state": "CA", "country": "US", "review_days": 56, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260842", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260846", "pathway": "510(k)", "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "parent": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.", "device": "Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-03-16", "product_code": "IYN", "device_class": "2", "state": "", "country": "CN", "review_days": 56, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260846", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252953", "pathway": "510(k)", "company": "Velmeni, Inc.", "parent": "Velmeni, Inc.", "device": "Velmeni for Dentists (V4D) Endo-Perio", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-09-16", "product_code": "MYN", "device_class": "2", "state": "CA", "country": "US", "review_days": 237, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252953", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K254178", "pathway": "510(k)", "company": "Asahi Intecc Co., Ltd.", "parent": "Asahi Intecc Co., Ltd.", "device": "SAYA 86 Radial Access Guide Catheter", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-12-23", "product_code": "QJP", "device_class": "2", "state": "", "country": "JP", "review_days": 139, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254178", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P200032/S005", "pathway": "PMA Supplement", "company": "Occlutech Holding AG", "parent": "Occlutech Holding AG", "device": "Occlutech Pistol Pusher", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-03-04", "product_code": "OZG", "device_class": "3", "state": "", "country": "US", "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename", "review_days": 68, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200032", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P250026", "pathway": "PMA", "company": "Siemens Healthcare Diagnostics, Inc.", "parent": "Siemens Healthcare Diagnostics, Inc.", "device": "Atellica IM free PSA II (fPSAII)", "category": "Diagnostics", "specialty": "Immunology", "status": "Approved", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-07-18", "product_code": "MTG", "device_class": "3", "state": "NY", "country": "US", "supplement_reason": "", "review_days": 297, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250026", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "N17600/S046", "pathway": "PMA Supplement", "company": "Davol Inc., Sub. C. R. Bard, Inc.", "parent": "Davol Inc., Sub. C. R. 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"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120008", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P030053/S083", "pathway": "PMA Supplement", "company": "Mentor Corp.", "parent": "Mentor Corp.", "device": "MENTOR\u0099 MemoryGel\u0099 Enhance Breast Implants", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Approved", "cleared": true, "decision_date": "2026-05-11", "date_received": "2025-08-07", "product_code": "FTR", "device_class": "3", "state": "CA", "country": "US", "supplement_reason": "Postapproval Study Protocol", "review_days": 277, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030053", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P930036/S026", "pathway": "PMA Supplement", "company": "Siemens Healthcare Diagnostics, Inc.", "parent": "Siemens Healthcare Diagnostics, Inc.", "device": "ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP)", "category": "Diagnostics", "specialty": "Immunology", "status": "Approved", "cleared": true, "decision_date": "2026-05-11", "date_received": "2026-01-21", "product_code": "LOK", "device_class": "3", "state": "MA", "country": "US", "supplement_reason": "Change Design/Components/Specifications/Material", "review_days": 110, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930036", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260385", "pathway": "510(k)", "company": "Carlsmed, Inc.", "parent": "Carlsmed, Inc.", "device": "aprevo\u00ae anterior and lateral lumbar interbody system; aprevo\u00ae posterior and transforaminal lumbar interbody system; aprevo\u00ae cervical interbody system; corra\u0099 cervical plating system", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-09", "date_received": "2026-02-06", "product_code": "MAX", "device_class": "2", "state": "CA", "country": "US", "review_days": 92, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260385", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261145", "pathway": "510(k)", "company": "Avanti Orthopaedics, LLC", "parent": "Avanti Orthopaedics, LLC", "device": "Avanti Distal Elbow ORIF System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-09", "date_received": "2026-04-07", "product_code": "HRS", "device_class": "2", "state": "DE", "country": "US", "review_days": 32, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261145", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253679", "pathway": "510(k)", "company": "Stryker Instruments", "parent": "Stryker", "device": "Hydro Irrigation System", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-11-21", "product_code": "GWG", "device_class": "2", "state": "MI", "country": "US", "review_days": 168, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253679", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253237", "pathway": "510(k)", "company": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi", "parent": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi", "device": "Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-09-29", "product_code": "GXY", "device_class": "2", "state": "", "country": "TR", "review_days": 221, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253237", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K250814", "pathway": "510(k)", "company": "Zeus Scientific", "parent": "Zeus Scientific", "device": "Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB", "category": "Diagnostics", "specialty": "Immunology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-03-17", "product_code": "OBE", "device_class": "2", "state": "NJ", "country": "US", "review_days": 417, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250814", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253396", "pathway": "510(k)", "company": "Apyx Medical Corporation", "parent": "Apyx Medical Corporation", "device": "AYON Body Contouring System\u0099 (AYON SYSTEM)", "category": "Surgical", "specialty": "General, Plastic Surgery", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-09-30", "product_code": "QPB", "device_class": "2", "state": "FL", "country": "US", "review_days": 220, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253396", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260321", "pathway": "510(k)", "company": "Orthopedic Driven Imaging, LLC", "parent": "Orthopedic Driven Imaging, LLC", "device": "HipGuide (V 1.0.0.0)", "category": "Imaging", "specialty": "Radiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2026-01-30", "product_code": "LLZ", "device_class": "2", "state": "FL", "country": "US", "review_days": 98, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260321", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "DEN250013", "pathway": "De Novo", "company": "Neurovalens Limited", "parent": "Neurovalens Limited", "device": "Modius Spero", "category": "Neurology", "specialty": "Neurology", "status": "Granted", "cleared": true, 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"device": "Disposable Stone Retrieval Balloon Catheter", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-09-19", "product_code": "GCA", "device_class": "2", "state": "", "country": "CN", "review_days": 231, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253013", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253991", "pathway": "510(k)", "company": "Orthofix Srl", "parent": "Orthofix Srl", "device": "Fitbone\u0099 Trochanteric, FITBONE\u00ae Transport and Lengthening System, FITBONE\u00ae TAA", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-12-12", "product_code": "HSB", "device_class": "2", "state": "", "country": "IT", "review_days": 147, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253991", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252617", "pathway": "510(k)", "company": "Intromedic Co., Ltd.", "parent": "Intromedic Co., Ltd.", "device": "MiroCam\u00ae Capsule Endoscope System", "category": "Other", "specialty": "Gastroenterology, Urology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-08-19", "product_code": "NEZ", "device_class": "2", "state": "", "country": "KR", "review_days": 262, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252617", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260419", "pathway": "510(k)", "company": "Hangzhou ChohoTech Co., Ltd.", "parent": "Hangzhou ChohoTech Co., Ltd.", "device": "LingOral Dental Design System", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2026-02-09", "product_code": "PNN", "device_class": "2", "state": "", "country": "CN", "review_days": 88, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260419", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252621", "pathway": "510(k)", "company": "El Global Trade, Ltd.", "parent": "El Global Trade, Ltd.", "device": "DeepSkin (DEP100)", "category": "Neurology", "specialty": "Neurology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-08", "date_received": "2025-08-19", "product_code": "NFO", "device_class": "2", "state": "", "country": "IL", "review_days": 262, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252621", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260788", "pathway": "510(k)", "company": "Smylio, Inc.", "parent": "Smylio, Inc.", "device": "Smylio Aligners", "category": "Dental", "specialty": "Dental", "status": "Cleared", 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(Dba Savelife.Ai)", "parent": "Neurocareai, Inc. 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BioCode, Inc.", "parent": "Applied BioCode, Inc.", "device": "BioCode\u00ae Respiratory Pathogen Panel (RPP)", "category": "Diagnostics", "specialty": "Microbiology", "status": "Cleared", "cleared": true, "decision_date": "2026-05-01", "date_received": "2025-12-22", "product_code": "OCC", "device_class": "2", "state": "CA", "country": "US", "review_days": 130, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254139", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252488", "pathway": "510(k)", "company": "Radiometer Medicals Aps", "parent": "Radiometer Medicals Aps", "device": "ABL90 FLEX PLUS System", "category": "Diagnostics", "specialty": "Clinical Chemistry", "status": "Cleared", "cleared": true, "decision_date": "2026-05-01", "date_received": "2025-08-08", "product_code": "CGA", "device_class": "2", "state": "", "country": "DK", "review_days": 266, "source_url": 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L. Gore & Associates, Inc.", "parent": "W. L. 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"id": "K252748", "pathway": "510(k)", "company": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "parent": "Hunan Accurate Bio-Medical Technology Co., Ltd.", "device": "Pelvic Floor Exerciser (PF01)", "category": "Women's Health", "specialty": "Obstetrics/Gynecology", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2025-08-29", "product_code": "HIR", "device_class": "2", "state": "", "country": "CN", "review_days": 241, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252748", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260182", "pathway": "510(k)", "company": "Zimmer, Inc.", "parent": "Zimmer, Inc.", "device": "Avenir\u00ae M\u00fcller Stem; Avenir Complete\u0099 Hip System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-01-21", "product_code": "LZO", "device_class": "2", "state": "IN", "country": "US", "review_days": 96, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260182", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252445", "pathway": "510(k)", "company": "Maquet Cardiovascular, LLC", "parent": "Maquet Cardiovascular, LLC", "device": "Fusion Bioline Vascular Graft", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2025-08-04", "product_code": "DSY", "device_class": "2", "state": "NJ", "country": "US", "review_days": 266, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252445", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252409", "pathway": "510(k)", "company": "Sight Sciences, Inc.", "parent": "Sight Sciences, Inc.", "device": "TearCare MGX System", "category": "Ophthalmic", "specialty": "Ophthalmic", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2025-08-01", "product_code": "ORZ", "device_class": "2", "state": "CA", "country": "US", "review_days": 269, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252409", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261357", "pathway": "510(k)", "company": "Voco GmbH", "parent": "Voco GmbH", "device": "Grandio disc multicolor", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-04-24", "product_code": "EBF", "device_class": "2", "state": "", "country": "DE", "review_days": 3, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261357", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261356", "pathway": "510(k)", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "parent": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "device": "Dura-Crown", "category": "Dental", "specialty": "Dental", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-04-24", "product_code": "EBF", "device_class": "2", "state": "", "country": "CN", "review_days": 3, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261356", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K260660", "pathway": "510(k)", "company": "Elevation Spine", "parent": "Elevation Spine", "device": "SABER-C System", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-03-02", "product_code": "OVE", "device_class": "2", "state": "CA", "country": "US", "review_days": 56, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260660", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K252628", "pathway": "510(k)", "company": "Wesper, Inc.", "parent": "Wesper, Inc.", "device": "Cassie", "category": "Anesthesiology", "specialty": "Anesthesiology", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2025-08-20", "product_code": "MNR", "device_class": "2", "state": "NY", "country": "US", "review_days": 250, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252628", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253658", "pathway": "510(k)", "company": "Diagnostica Stago, Inc.", "parent": "Diagnostica Stago, Inc.", "device": "STA Satellite Max\u00ae", "category": "Diagnostics", "specialty": "Hematology", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2025-11-20", "product_code": "JPA", "device_class": "2", "state": "NJ", "country": "US", "review_days": 158, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253658", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K261032", "pathway": "510(k)", "company": "NovoSource", "parent": "NovoSource", "device": "NovoKnee (SteriKnee)", "category": "Orthopedic", "specialty": "Orthopedic", "status": "Cleared", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-03-30", "product_code": "JWH", "device_class": "2", "state": "WV", "country": "US", "review_days": 28, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261032", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "P200026/S018", "pathway": "PMA Supplement", "company": "Medtronic Vascular, Inc.", "parent": "Medtronic", "device": "Abre\u0099 Venous Self-expanding Stent System", "category": "Cardiovascular", "specialty": "Cardiovascular", "status": "Approved (30-day notice)", "cleared": true, "decision_date": "2026-04-27", "date_received": "2026-04-08", "product_code": "QAN", "device_class": "3", "state": "MN", "country": "US", "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier", "review_days": 19, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200026", "first_seen": "2026-07-28", "last_seen": "2026-08-24" }, { "id": "K253580", "pathway": "510(k)", "company": "Tedan Surgical Innovations", "parent": "Tedan Surgical Innovations", "device": "Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)", "category": "Other", "specialty": "Ear, Nose, Throat", "status": "Cleared", "cleared": true, "decision_date": "2026-04-26", "date_received": "2025-11-17", "product_code": "PDQ", "device_class": "2", "state": "TX", "country": "US", "review_days": 160, "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253580", "first_seen": "2026-07-28", "last_seen": "2026-08-24" } ] }