510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,732
176,529 records, page 1964 of 3531
510(k) clearances, page 1964 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K962154Carbomedics HandleCarbomedics, Inc.DTJClass I
K962117Quadrature and Phased Array Flexible Body CoilsPhilips North America LLCLNHClass II
K962099Cedia Procainamide AssayBoehringer Mannheim Corp.LARClass II
K961718Dei Model 20 EEGDiscovery Engineering Intl., Inc.HCCClass II
K961587Iron (Total) Assay Catalogue No. 102-10, 102-25Sekisui Diagnostics P.E.I. Inc.JMOClass I
K960435Phoenix Crx ValvePhoenix Biomedical Corp.JXGClass II
K960356Posterior Annuloplasty Band (Model 607)The Heart Valve Div. Medtronic Cardiovascular SurgKRHClass II
K960205CPR Tracheotomy Care TrayCustom Pack ReliabilityBTOClass II
K955880Direct Bilirubin (Dnd) Assay, Catalogue Number 209-05Sekisui Diagnostics P.E.I. Inc.CIGClass II
K963284Raven Eye- Eye Wear (Sunglasses)Raven Eye, Inc.HQYClass I
K963083Linea Milano Sunglasses, Kaleido Sunglasses Plastic and Metal FramesPiazza Optical Corp.HQYClass I
K962940Raven Eye, Inc.- Eye WearRaven Eye, Inc.HQYClass I
K962279Acrylic Reading and Polycarbonate Lenses SunglassesJane Fui Optical Co., Ltd.HQYClass I
K962121Horizon/westhin 55-GWestcon Contact Lens Co., Inc.LPLClass II
K962085Salter Labs 8990 Series NebulizerSalter LabsCAFClass II
K961250Dynatron 125 UltrasoundDynatronics Corp.IMIClass II
K960767Light CommanderScieran Technologies, Inc.FCTClass II
K960424Buechel-Pappas Polyethylene Glenoid Component (02-11-Yyxx) Note:yy=id & Xx=odEndotec, Inc.KWTClass II
K963194Ito Acupuncture NeedlesOms Medical Supplies, Inc.MQXClass II
K963182Elecsys Calcheck Ck-MbBoehringer Mannheim Corp.JJXClass I
K963147Elecsys Calcheck TshBoehringer Mannheim Corp.JJXClass I
K963143Elecsys Calcheck Troponin TBoehringer Mannheim Corp.JJXClass I
K963059Sunquest InternationalSunquest Intl., Inc.HQYClass I
K963005Nova 16 Analyzer (Modification Point of Care Usage)Nova Biomedical CorporationJFLClass II
K962982Nova Chemistry Controls, Level 1,2,And 3 W/o CreatNova Biomedical CorporationJJYClass I
K962916Hua-Xia Acupuncture NeedlesLhasa Medical, Inc.MQXClass II
K962906Scripps Laboratories Hcg One-StepScripps Laboratories, Inc.JHIClass II
K962875Active Ultrasensitive Unconjugated Estriol EiaDiagnostic Systems Laboratories, Inc.CGIClass I
K962866Opus HlhBehring Diagnostics, Inc.CEPClass I
K962779Compression ScrewOrthopaedic Biosystems, Ltd.HWCClass II
K962196Nexgen Knee Prosthesis & Legacy Knee Prosthesis W/co-Nidium Surface Hardening ProcessZimmer GmbHJWHClass II
K962131Storz D4600 Air Exchange Line PackStorz Instrument Co.HQCClass II
K962095Medline Powder-Free Non-Sterile Latex Examination Gloves,medline Powder-Free Sterile Latex Examination GlovesMEDLINE INDUSTRIES, LP - NorthfieldLYYClass I
K962094Medline Pre-Powdered Non-Sterile and Sterile Latex Examination GlovesMEDLINE INDUSTRIES, LP - NorthfieldLYYClass I
K962080Rps-50 Beam ScannerSofield Science Services, Inc.IYEClass II
K962076Medline Pwder-Free Vibnyl Examiunation Gloves/vinyl Gloves, Sterile (Mds 192074,5,6)MEDLINE INDUSTRIES, LP - NorthfieldLYYClass I
K962051Aspect OpticamAspect Electronics, Inc.LMCClass II
K961721Steritec Disposable Biological Test PackSteritec Products Mfg. Co., Inc.FRCClass II
K961699Equipment CoversUnited States Surgical, A Division of Tyco HealthcMMPClass II
K961311Hemocue B-Glucose SystemHemoCue ABLFRClass II
K961263Model 1200 Abmulatory Infusion PumpPatient Solutions, Inc.FRNClass II
K961103Benz 38 Clear & with Blue Visibility TintBenz Research and Development LLCLPLClass II
K961083Orex Surgeon's VestThantex Specialties, Inc.FYAClass II
K960826Cadd-Prizm Model 6100 PumpSims Deltec, Inc.FRNClass II
K954594Reticulocyte Method, Rbc IndicesBayer Corp.GKZClass II
K954576Axsym Toxo IgmAbbott MedicalLGDClass II
K963075Fito DidoFramesmart, Inc.HQYClass I
K962912Marcella CaranFramesmart, Inc.HQYClass I
K962665A-Dec Self-Contained Water SystemA-dec, Inc.EIAClass I
K962241Gore Spherex ImplantW. L. Gore & Associates, Inc.HPZClass II