510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 2910 of 3529
510(k) clearances, page 2910 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K86046937-701-1 Patient Doase Monitor with DetectorsVictoreen, Inc.KPZClass II
K855061Curity Percutaneous Catheter Insertion KitThe Kendal Co.DYBClass II
K855060Curity Percutaneous Catheter Insertion TrayThe Kendal Co.DYBClass II
K855019Durahesive Protective Barrier WipeConvatec, A Division of E.R. Squibb & SonsEXBClass I
K854941Pms Percutaneous Puncture NeedleProfessional Medical ServicesDYBClass II
K854912Angiomed Guied WiresAngiomed U.S., Inc.DQXClass II
K854710Bottoms-Up Tm Pelvic Spinal Posture-AidReloke Co.KNNClass I
K861264Joint Measurement IndicatorDevcom, Inc.JDLClass III
K861219Accupac Custom Skin Scrub KitGeneva Laboratories, Inc.
K861178Depuy Compression Hip Screw SystemDepuy, Inc.KTTClass II
K861154Alba Health Care Plain Packing StripAlba Health CareEFQUnclassified
K861151Suel Blood LancetExel Intl.FMKClass II
K861064Lm-850 Automatic LensmeterNidek, Inc.HLMClass I
K860915Storz/mazzacco Lens ForcepStorz Instrument Co.HNRClass I
K860894Behring Nephelometer SystemBehring Diagnostics, Inc.CFNClass II
K860642Photron Visual Field AnalyzerBiosan Laboratories, Inc.HOMClass I
K860278Model 525-25 Watt CO2 Laser for Derma/plasticBritt Corp., Inc.GEXClass II
K860175Cd-200 Cardiac MonitorCardio Display Corp.DPSClass II
K854810Fc-1000 Fluoroscopic Imaging ComputerInficon Leybold-Heraeus, Inc.LLZClass II
K854807Life PacLifemed Technologies, Inc.KZDClass I
K861138Mash DermatomeMecron Medical Products, Inc.GFDClass I
K861105Howmedica Bipolar ProsthesisHowmedica Corp.KWYClass II
K861086Zimmer Vacuum Mixing SystemZimmer GmbHJDZClass I
K861076Residential Tanning UnitSunmaker, Inc.FTCClass II
K860899Dispette IIUlster Scientific, Inc.JPHClass I
K860747Du Pont Sorvall Centrifuges (Rapidspin R)E.I. Dupont de Nemours & Co., Inc.JQCClass I
K860101Mx4040 Intrauterine Pressure Monitoring KitMedex, Inc.KXOClass II
K854996Ultrasonic Couplant GelJohnson & Johnson Professionals, Inc.JOPClass II
K854349Tiger's Digital ThermometerTiger Electronics, Inc.FLLClass II
K854311EarlensSound Acoustic Systems, Ltd.ESDClass I
K853706Bomed-CdmBomed Medical Mfr., Ltd.DSBClass II
K861330Sechrist Airway Pressure Monitor Model 600Sechrist Industries IncCAPClass II
K861286Gas Sampling KitRespiratory Support Products, Inc.BZOClass I
K861270Blue Ribbon Paraffin Infiltration/embedding Med.Surgipath Medical Industries, Inc.KEOClass I
K861259Macconkey W/mugRemel IncJTOClass I
K861253Tissue Culture Flask Pl 732 PlasticTravenol Laboratories, S.A.KJAClass I
K861245Orthosource Etch SystemsOrtho SourceEBCClass II
K861201Formaldehyde Solution, 37%Surgipath Medical Industries, Inc.IGGClass I
K861150Exel Dental NeedleExel Intl.DZMClass I
K860919Therachem, Tdc Therapeutic Drug ControlsFisher Scientific Company L.L.C.DIFClass I
K860895Cefotetan 30 Mcg Antimicrobial Susceptibility DiskbioMerieux, Inc.JTNClass II
K860812Sickle Cell Reagent SetMichClone Associates, Inc.GHMClass II
K860759Charisma Hearing AidBernafon LLCESDClass I
K860717Enzymatic Cholesterol Reagent (Single Vial)Trace Scientific, Ltd.CHHClass I
K860670Dahlberg Model Ut in-the-Ear Hearing AidDahlberg Electronics, Inc.ESDClass I
K860663Amresco Flow Pac Creatine Phosphokinase ReagentAmresco, Inc.JHYClass II
K860633Fluoroseal, Dentin Sealer and Cavity LinerScientific Pharmaceuticals, Inc.LBHClass II
K860525Abuscreen Radioimmunoassay for Lsd W/ Ref StandardRoche Diagnostic Systems, Inc.DLBClass II
K860500Emit D.a.u. Cannabinoid 20Ng AssaySyva Co.LDJClass II
K860422Strat Thyroid Uptake Fluromet Enzyme ImmunoassayAmerican DadeKHQClass II