510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3208 of 3528
510(k) clearances, page 3208 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K822198Malleus NippersKelleher Corp.JEKClass II
K822195Mircosurgical InstrumentsKelleher Corp.JYLClass I
K822186Mackenzie's TonsillectomeKelleher Corp.KCAClass I
K822177Audiometers (Various Models)Kelleher Corp.GWJClass II
K821978Sterile Urethral Catheterization SetMedical Devices Inc.KNXClass II
K821758Quinton Q, Scan Models 900 & 901Quinton, Inc.DPSClass II
K821691StimriteBiotone International, Inc.EPFClass II
K827858Model 835 Spot Film DeviceGeneral Electric Co.
K827816Podiatry X-Ray UnitThe S. S. White Co.
K827815Sonoline 6000Siemens Medical Solutions USA, Inc.
K827796Innoscan Examination LightInnomed, Inc.
K822388Life Trace 14Life Science Instrumentation, Inc.DRTClass II
K822378TENS ElectrodeFranklin Sales & Mfg. Co.GXYClass II
K822350Swan-Ganz Flow-Directed Thermodil. CathAmerican Edwards LaboratoriesDYGClass II
K822313Procedure #430 & Reagents for AcetaminSigma Chemical Co.LDPClass II
K822293Immu-Count 404Kemble Instruments, Inc.JJJClass I
K822289Co2/ci StandardsGilford DiagnosticsJIXClass II
K822243Guiding CatheterInterventional Medical, Inc.DQOClass II
K822210Sarns Cardioplegia Cannulae (Var. Types3M Health Care, SarnsDWFClass II
K822193Forceps for Use with Rigid EndoscopesKelleher Corp.JEKClass II
K822188Tonsil SnaresKelleher Corp.KBZClass I
K822187Tonsil DissectorsKelleher Corp.KTGClass I
K822170Incus NippersKelleher Corp.JYRClass I
K822155Ethicon Temporary Cardiac Pacing WireEthicon, IncLDFClass II
K822144Ids Staphylochrome TestInnovative Diagnostic Systems, Inc.JWXClass I
K822100High Pressure Contrast Injection LineNamicDQOClass II
K822071Pump Modules Pmo Lo-110-Pmd 10-210Gambro, Inc.DWBClass II
K822068Gambro Pump Console CslGambro, Inc.DTQClass II
K822034Balloon Wedge Pressure CatheterZiehm International, Inc.DYGClass II
K822033Berman Angiographic Balloon CatheterZiehm International, Inc.DQOClass II
K821942Harvey-Bostwick Brady Cardia Monit. Hb85Harvey-Bostwick, Inc.DRTClass II
K821816Angiographic CatheterMedi-Tech, Inc.DQOClass II
K827890Foldalite UnitNational Biological Corp.FTCClass II
K827818Doppler Flow Meter, LaserAtl Interspec Cardiology
K822379Disposable Anesthesia Breathing CircuitMarquest Medical Products, Inc.CAIClass I
K822356Modulaide Emerg. Cardiac Life Supp. KtLaerdal Medical a/SBTMClass II
K822321Ioi 32 Tm Femoral ComponentIntermedics OrthopedicsKWLClass II
K822311Disposable Collection Bottle W/tubingOhio Medical ProductsGCXClass II
K822305Ortho-LevelFrontier ProductsHTHClass I
K822295Surgi Tek's Dispos. Inner Cannula forMedical Engineering Corp.BTOClass II
K822254Electric Cord for EndoscopeKelleher Corp.FFZClass II
K822203Knife HandleKelleher Corp.KTGClass I
K822192Fiberoptic Light CarriersKelleher Corp.EQHClass I
K822191Head Mirror with HeadbandKelleher Corp.KAIClass I
K822180Rigid Fiberoptic EndoscopesKelleher Corp.EOQClass II
K822175Adaptor for Fiberoptic Light SourceKelleher Corp.EQHClass I
K822169Surgical Head SupportKelleher Corp.HBMClass I
K822167Still Endoscopic CamerasKelleher Corp.FXMClass I
K822166Microsurgical Ear HookKelleher Corp.JYLClass I
K822105Lens Easy onL.E.O. Corp.HPXUnclassified