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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 3436 of 3526
510(k) clearances, page 3436 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K781426Cardial Pulse GeneratorsTelectronics, Inc.DXYClass III
K781422Kwik-Flo Urinal SystemThe Grace Mfg. Co.KNXClass II
K781415Cannula, Nasal, OxygenVitalab Products Corp.CATClass I
K781414Mask, Oxygen, NonbreathingVitalab Products Corp.KGBClass I
K781413Mask, PxygenVitalab Products Corp.DPTClass II
K781406Hydron Burn Bandage Manual ApplicationAbbott MedicalKMFClass I
K781404Bed Pads: D-12 and D-8Grant Airmass Corp.FNMClass II
K781385Dobbhoff Enteric Feeding BagBiosearch Medical Products, Inc.FPDClass II
K781360Model 80100A, Patient Data MemoryHewlett-Packard Co.HGMClass II
K781230Gavage Admin. SetMcgaw LaboratoriesKNTClass II
K781228PenlightsAbco Dealers, Inc.KYTClass I
K781178Pulse Generator Model 208Elema-Schonander, Inc.DXYClass III
K781176Patient Aid, Model Dm-351Extracorporeal Medical Specialities, Inc.FKQClass II
K781140Cutter Resiflex Foley CathetersCutler Laboratories, Inc.DJCClass II
K781090Generator, Cardiac Pulse, 250BTelectronics, Inc.DXYClass III
K781064Dinamap Model 848Applied Medical ResearchDSKClass II
K781053Dinamap Model 846Applied Medical ResearchDSKClass II
K781014Autorefractor, SubjectiveCavitron Corp.HKOClass I
K780899Fluorescent Anti-Native DNA TestKallestad Laboratories, Inc.DHNClass II
K780872Cytology BrushCooperVision, Inc.BTGClass II
K780706Lumbar Nerve Root ShieldHeyer Schulte Corp.
K781390Mycoplasma Hyorhinis (Bts-7)Flow Laboratories, Inc.KPBClass I
K780886System 6000 Automated Ria AnalyzerBeckman Instruments, Inc.LCIClass I
K780772Bjork-Shiley Cardiac Heart ValveShiley, Inc.
K781439Hearing Aid, Unitron Model 958Unitron Industries, Inc.ESDClass I
K781434Hearing Aid, Unitron Model 975Unitron Industries, Inc.ESDClass I
K781429Hand-Trol Connector ExtenderAspen Laboratories, Inc.GEIClass II
K781423Dual Component StandardsAbbott MedicalJITClass II
K781418Xomed Transsphenoidal HandpieceXomed, Inc.ERLClass II
K781395Disposable Aerosol T Briggs AdaptorInhal-O-Tech Medical PlasticBZAClass I
K781355Ics Normal Control SerumBeckman Instruments, Inc.DGRClass I
K781349Pacer-Tracer Pulse WidthInstromedix, Inc.DTCClass II
K781345Ultrafill- UltraboundDemetron Research Corp.EBDClass II
K781342Glucose TestWako Intl., Inc.CGAClass II
K781335Digoxin Ria (Peg) KitOrtho Diagnostics, Inc.DOGClass II
K781330Blood Level Detector-Model 7601BD Becton Dickinson Vacutainer Systems PreanalyticFJFClass II
K781324Alp TestAnalytical & Research Chemicals, Inc.CIOClass II
K781323Ldh ProcedureAnalytical & Research Chemicals, Inc.
K781310Human Chorionic Gonado.-Beta Ria KitDiagnostics Biochem Canada, Inc.JHIClass II
K781309Got ProcedureAnalytical & Research Chemicals, Inc.
K781308GlucolourAnalytical & Research Chemicals, Inc.CGEClass II
K781307Glucose Determ. KitAnalytical & Research Chemicals, Inc.CGAClass II
K781306Urea Nitrogen Test KitAnalytical & Research Chemicals, Inc.CDLClass II
K781305Urea NitrogenAnalytical & Research Chemicals, Inc.CDWClass II
K781296Thyro-ShureNuclear Medical Laboratories, Inc.JLWClass II
K781284Rabbit Antibody to Human T3Pcl-Ria, Inc.CDPClass II
K781278Gloves, ProcedureArbrook Mfg. Corp.FMCClass I
K781275Chloride/carbon Dioxide Reagent SetNobel Scientific Industries, Inc.JFSClass II
K781251Threaded Pin, Self DrillingAce Orthopedic Manufacturing Co.JDWClass II
K781244Temp. Crown Msterial for TeethDen-Mat Corp.EBGClass II