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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 3115 of 3528
510(k) clearances, page 3115 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K831849Pleural Drainage Sys #Pds-100-4American BentleyCACClass II
K831507Low Trauma Arterial Filter H-640C.R. Bard IncDTMClass II
K834163UltravitAmerican Surgical Company, LLCHQEClass II
K834161Universal PacAmerican Surgical Company, LLCHQCClass II
K834159Phacotron PlusAmerican Surgical Company, LLCHQCClass II
K834158Extra Sensory PlusAmerican Surgical Company, LLCHQCClass II
K833940Torque Plus Catalog 30120Concept, Inc.HWEClass I
K833697Extra Sensory Pak-Dispos. AccessAmerican Surgical Company, LLCHQCClass II
K833617Extra Plus TmAmerican Surgical Company, LLCHQCClass II
K833432Catheter Insertion KitClinipad Corp.KODClass II
K832917Port-a-CathPharmacia, Inc.LJTClass II
K834177H.r. Jakobi Surg. Instruments #4 30/31Imm Enterprises, Ltd.HGEClass I
K834174Op-Con Surgical Instruments #4Imm Enterprises, Ltd.HCZClass II
K834173Op-Con Surgical Instruments #4Imm Enterprises, Ltd.LBXClass II
K834098Stationary Exercise BicycleEngineering Dynamics Corp.ISDClass II
K834078Silicone Rugger Disposable Yoke-CPAPVesta, Inc.BTQClass I
K834076Arthroscopic Leg Holder 434-21Custom Medical Products, Ltd.HRXClass II
K834065A3bRemel Co.JSNClass I
K834027Gold SeadsRadiation Safety & Nuclear Products, Inc.IWGClass II
K834013Sf BrothMicro Media LaboratoriesJSDClass I
K833927Electro-Myoscope 85Biomedical Design InstrumentsIKNClass II
K833920Kelly CholangiocathPerry, Div.FGEClass II
K833904Temptrend IIBiosynergy, Inc.KPDClass II
K833879Cardiopulmonary ResuscitatorMichigan InstrumentsDRMClass II
K833871Universal Control ArmAnesthesia Assoc., Inc.CAIClass I
K833866Ace/kyle Self Tapping Cannulated TitaBuckman Co., Inc.JPWClass I
K833860Tuck-Tite Colon Fluid RetainerClayton Medical Products, Inc.FCEClass I
K833839BiothermTrileen, Inc.ILJClass II
K833811Cardiac CameraSiemens Gammasonics, Inc.IYXClass I
K833790Curity 100% Silicone Coude' CatheterThe Kendal Co.KODClass II
K833749Peritoneal Catheter-Changes-Quinton, Inc.FKXClass II
K833740Venoset Multi-Med Piggyback W/ivex-2Abbott MedicalFPAClass II
K833738Leap Strep Test KitCooper Biomedical, Inc.GTPClass I
K833733Non - Adherent BandageAmerican Medical Disposable, Inc.FROUnclassified
K833715Emit Netilmicin AssaySyva Co.LCEClass II
K833700Aca Thyroxine CalibratorE.I. Dupont de Nemours & Co., Inc.JITClass II
K833684Ivex-IntAbbott MedicalFPBClass II
K833683Chem Kit Theophylline Diag. KitAbbott MedicalKLSClass II
K833664Armboard and the BoardRick Robbin & Frederick AuerbachBTXClass I
K833657Angio-Set Intravenous Cath. SetDeseret Medical, Inc.FOZClass II
K833638Dermatex Sterile Finger BandageDermatec, Inc.NADClass I
K833592X-Beam Film 3TcAmorient Ent.
K833582Pulsator Arterial Blood Sampling SyrinConcord Laboratories, Inc.CBTClass I
K833569Comfeel Barrier CreamMEDLINE INDUSTRIES, LP - NorthfieldEXBClass I
K833566Comfeel CleanserMEDLINE INDUSTRIES, LP - NorthfieldEXBClass I
K833512Partial Denture AlloyDentsply Intl.EJHClass II
K833477Intersept 40 Micron FilterExtracorporeal Medical Specialities, Inc.DTMClass II
K833476Intersept 40 Micron Filter W/tubingExtracorporeal Medical Specialities, Inc.DTMClass II
K833474Viralizer Nebulizer SprayerViral Response System, Inc.CCQClass I
K833473Dentin Bonding AgentJohnson & Johnson Professionals, Inc.KLEClass II