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 3448 of 3526
510(k) clearances, page 3448 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K780446Sutureless Myocardial Pacing LeadMedtronic, Inc.DTBClass III
K780427Rp-510/Rp-514 Parallel Plate DialyzersHospal Medical Corp.FJGClass II
K780307Cardiac MinigraphArco Medical Products Co.DPSClass II
K780297Cardiac Miniscope & MinigraphArco Medical Products Co.DRTClass II
K780224Microcell Counter Model Cc-108Toa Medical Electronics USA, Inc.GKLClass II
K780729Las-R Human Complement Clq TestHyland Therapeutic Div., Travenol LaboratoriesDAKClass II
K780636Single Vial 10 Sgpt-TrisBoehringer Mannheim Corp.CKAClass I
K780634Single Vial 10 Sgot-TrisBoehringer Mannheim Corp.CITClass II
K780557Folate Reagent Kit, Aria-II SystemBD Becton Dickinson Vacutainer Systems PreanalyticCGNClass II
K780348Epilation Type DeviceMehl, Thomas L.KCXClass I
K780327Generators, Atrial Inhibited PulseMedtronic, Inc.DXYClass III
K780712Kerr Discovery Disposable Fluoride TrayKerr Corporation (Danbury)KMTClass I
K7806774600 RecorderG & W Applied Science LaboratoriesDSFClass I
K780664Soft Lens Remover/inserter/manipulatorDmv Contact Lens Co.KYEClass I
K780663Contact Lens Remover and InserterDmv Contact Lens Co.KYEClass I
K780777Bags, Plastic, Sterile for GeneratorsTelectronics, Inc.DXYClass III
K780771Micro RaspsAmsco Co.HTRClass I
K780763Entrax Traction UnitOrthopedic Equipment Co., Inc.HSRClass I
K780749Speech Audiometer Ra 226Tracor Instruments, Inc.EWOClass II
K780701Dental Office Environment Control UnitLaminaire Corp.EHZClass I
K780673Central Catheter KitArgon Medical Corp.FPKClass II
K780586Microclip, WilliamsRichard'S Medical Equip., Inc.GDWClass II
K780584Pulmonary Function TesterWarren E. Collins, Inc.BTYClass II
K780520Vas ApproximatorEdward Weck, Inc.HAOClass I
K780473Ilex Stoma Seal and Protective CreamVirgil PichierriEXBClass I
K780449Beta Cap SystemQuinton, Inc.FJSClass II
K780385Respiratory Therapy Solutions - FlexibleTravenol Laboratories, S.A.BTTClass II
K780381Respiratory Therapy Solutions - FlexibleTravenol Laboratories, S.A.BTTClass II
K780755Shortwave Diathermy Model 802Birtcher Corp.IMJClass II
K780746Hygienic Rubber Dam FrameHygienic Dental Mfg., Co., theEJEClass I
K780745Rubber DamHygienic Dental Mfg., Co., theEIEClass I
K780744Brinker Tissue RetractorsHygienic Dental Mfg., Co., theEEFClass I
K780743Clamp ForcepsHygienic Dental Mfg., Co., theEJGClass I
K780713Culture SwabRoyal Scientific, Inc.JRWClass I
K780709In Vitro Gentamicin Radioimmunoassy TestClinical Assays, Inc.
K780704Columbia Agar with 5% Rabbit BloodGranite Diagnostics, Inc.JSIClass I
K780698Stimulators, Nerve, ElectricalMed GeneralGZJClass II
K780694Hearing Aid Battery ChargerCahill Enterprises, Inc.ESDClass I
K780583Fome-Cuf PVCBivona Medical TechnologiesBTRClass II
K780522Spectrophotometers, Atomic AbsorptionInstrumentation Laboratory Co.JXRClass I
K780521Spectrophotometer, Atomic AbsorptionInstrumentation Laboratory Co.JXRClass I
K780463Ast(got) Uni-UV, SgotSclavo, Inc.CITClass II
K780462Alt(gpt) Uni-UV, SgptSclavo, Inc.CKAClass I
K780436Relax-a-ToneBio ResponseHCCClass II
K780402Power StriderSeidel Manufacturing, Inc.ITIClass II
K780379Data-Zyme Triglyceride ProcedureData Medical Associates, Inc.CDTClass I
K780330Total Hip, Lord MadreporicHowmedica Corp.KWAClass III
K780730FiguretrimJay-Mar INternational Enterprises, inISBClass II
K780723Otoscope SpeculaAbco Dealers, Inc.EPYClass I
K780710Air Massage SystemTheracom C/O Arent, Fox, Kintner, PlotkiIRPClass II