510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3491 of 3526
510(k) clearances, page 3491 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770511Cannula, Intravenous, HeparinizedSherwood Medical IndustriesFOZClass II
K770499Patient Turning and Repositioning G Dev.Patient Healthguards Corp.FMRClass I
K770486Sheet Kit, Stretcher, DisposableAmerican Hospital SupplyKMEClass I
K770481Shear, Plastic Handle Utility S-475-7Acme United Corp.JOKClass I
K770479Laceration KitAmerican Hospital SupplyFMCClass I
K770459Uric Acid Procedure, Tekpoint DirectIcn Pharmaceuticals, Inc.CDHClass I
K770754Duodenoscope, Molel Tx-6American Cystocope Makers, Inc.FOGClass I
K770742Cutter Cast 7Cutter Laboratories, Inc.ITGClass I
K770729Pyeloscope SystemRichard Wolf Medical Instruments Corp.FGAClass II
K770728Intraocular LensMilton Roy Co. Analytical
K770726Ria Kit, T4 ClaspSquibb & Sons, Inc.CDXClass II
K770721Monitors, Remote, Rms IIIRevvity Health Sciences, Inc.CCKClass II
K770691Gambro Venous Blood LineGambro, Inc.KOCClass II
K770670Flor. Conjug. Human Fab FragmentKent Laboratories, Inc.DFKClass I
K770669Rhodamine-Conjugated AntiserumKent Laboratories, Inc.DEWClass II
K770668Fluorescein Conjugated AntiserumKent Laboratories, Inc.DEWClass II
K770646Electrosurgical Patient Grounding PadC.R. Bard IncGEIClass II
K770597Dasp Tm Anti-RabbitOrganon LLCDEWClass II
K770474Thyroscreen Tm T4 Diagnostic KitAbbott MedicalCDXClass II
K770714Catheter, Arterial EmbolectomyMallinckrodt Critical CareDXEClass II
K770713Monitor, Patient, Resp. Carbon DioxideCavitron Corp.CCKClass II
K770709Probe, Temperature, System, Sarns3M Health Care, SarnsDRFClass II
K770566Immunoelectrophoresis Profile KitKallestad Laboratories, Inc.JZSClass I
K770467In Vitro Diagnostic TestHoffmann-La Roche, Inc.
K770727Manipulator & Injector, UterineNational Catheter Co. Div. MallinckrodtKNAClass II
K770725Stimulator, Muscle, Model 107Jaytronics, Inc.GZIClass II
K770719Immunoelectrofilm KihKallestad Laboratories, Inc.JZSClass I
K770718Stain, R-250, Coomassie Brilliant BlueKallestad Laboratories, Inc.JZSClass I
K770716Generator, Pulse, Unipolar, Model #504Cardiac Pacemakers, Inc.DXYClass III
K770712Trocar Sleeve System 4Mm to 3.4MmRichard Wolf Medical Instruments Corp.GCJClass II
K770711Trocar Sleeve System, 6.5Mm to 5.0MmRichard Wolf Medical Instruments Corp.GCJClass II
K770710Needle, SprayRichard Wolf Medical Instruments Corp.HRXClass II
K770692Monitor, Fetal, No. L04-1100Brattle Instrument Corp.HGMClass II
K770685Light, Examining, Dental, Ultra VioletParker Laboratories, Inc.EAQClass II
K770684Crown, Acrylic, Coral Brand, PreformedParker Laboratories, Inc.ELZClass I
K770683Bottle, Blood Culture, Bi-PhasicGibco Laboratories Life Technologies, Inc.JTWClass I
K770681Valve, Pressure Relief, Blood OxygenatorScimed Life Systems, Inc.KRIClass I
K770675Computer, Cardiac Output, Model Km275Lexington InstrumentsDXGClass II
K770674Curette, Uterine, Vacuum AspiratingAmerican Hospital SupplyHHKClass II
K770663Feedback EMG System, Model Pe-L00Bio-Feedback Systems, Inc.HCCClass II
K770661Generator, Pulse, ImplantableMed Telectronics, Ltd.DXYClass III
K770657Generator, Pulse, Cardiac 2LuEdwards Pacemaker SystemsDXYClass III
K770656Generator, Pulse, Cardiac 20UEdwards Pacemaker SystemsDXYClass III
K770575Echoencephalograph, Digital, 1000Storz Instrument Co.GXWClass II
K770561Catheter,percutaneous Introduc. & SheathUsci, Div. C.R. Bard, Inc.DYBClass II
K770546Blood ReservoirDelta Medical IndustriesDTNClass II
K770401Ldh/nadh,ldh/nadh, Nad & Nad DiaphoraseBD Becton Dickinson Vacutainer Systems PreanalyticJJIClass I
K770400Reagent, Amylase LipaseBD Becton Dickinson Vacutainer Systems PreanalyticKHMClass II
K770393Propane, High Purity, Instrument GradeHycel, Inc.JJOClass I
K770715Generator, Pulse, Bipolar, Model #604Cardiac Pacemakers, Inc.DXYClass III