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 3209 of 3528
510(k) clearances, page 3209 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K822098Bt 794-Blood/fluid WarmerElectromedics, Inc.LGZClass II
K821819Pigtail StentsAmerican Endoscopy, Inc.FGEClass II
K821714Porocoat Standard Metal Backed CupDepuy, Inc.JDIClass II
K821713Porocoat Low Profile Metal Backed CupDepuy, Inc.JDIClass II
K820811Proximate Disposable Skin StaplersEthicon, IncGAGClass II
K822387Behind-the-Ear Model Series 123Danavox, Inc.ESDClass I
K822320Kampner Femoral ComponentIntermedics OrthopedicsKWLClass II
K822301Royal 1 Oxygen ConcentratorProto-Med, Inc.CAWClass II
K822247Cath-SealUniversal Medical Instrument Corp.DYBClass II
K822151Surgical Instruments Represent. 4 ClassRobert I. Chien & Assoc., Inc.HNFClass I
K822084Pro-SpecExitec, Inc.HIBClass II
K822072Mpi Electrosurgical Capactive DisperMedical Plastics, Inc.GEIClass II
K822070Elite #Mps 101 Electrosurgical SwitchDelta Medical Electronics, Inc.GEIClass II
K822069Eliminator #Bps 201 Bipolar ElectroDelta Medical Electronics, Inc.GEIClass II
K822062Ball Tip Coagulating ElectrodesAmerican Endoscopy, Inc.GEIClass II
K822040Powered Emergency VentilatorFraser Harlake, Inc.CBKClass II
K822001Fri Alit Dental Implant -TubingFriedrichsfeld GmbHDZEClass II
K821987Earette Hearing Aid Opticon Model E28pOticon, Inc.ESDClass I
K821532Periguard Pericardial PatchGenetic Laboratories, Inc.DXZClass II
K821258SeloporSelomas, Inc.FROUnclassified
K821065Datascope 10.5 French Intra-Aortic BalDatascope Corp.DSPClass II
K827792Siremobile 3Siemens Medical Solutions USA, Inc.
K827748Thyro-Count Thyroid Uptake System 90Izd ProbeKemble Instruments, Inc.
K827718UnknownCranbury Medical Labs, Inc.
K827712Light Pen Accessory for Use with Fetascan 800 SeriesCranston Medical Laboratory
K827663Sinuson 810 Ultrasound ScannerAm Labs, Inc.
K827662Auto-Tech GeneratorBennett X-Ray Corp.
K827573Diasonics Cardio/imaging EchoscopeDiasonics, Inc.
K827503Sonoline 1000, 8008 and 8080Siemens Medical Solutions USA, Inc.
K822361Dianeal Solution Exchange Device #5C4193Travenol Laboratories, S.A.FKXClass II
K822352Hematoxylin Stain SolutionFisher Scientific Company L.L.C.HYJClass I
K822332C-Reactive Protein Test KitSclavo, Inc.JISClass II
K822308Vancomycin Fluorescent ImmunoassayAmerican Diagnostic Corp.LEHClass II
K822270Various Types of ENT ElevatorsKelleher Corp.KADClass I
K822266Nagashima Kn-52 Saccade & Pursuit StimKelleher Corp.GWNClass II
K822263Various Types of Tonsils HemostatsKelleher Corp.HRQClass I
K822237Urea Nitrogen Reagent Set (Mod. BerthelSterling Biochemical, Inc.CDLClass II
K822232Aca Urinary Protein CalibratorE.I. Dupont de Nemours & Co., Inc.JISClass II
K822227Immo Phase Fsh RadioimmunoassayCorning Medical & ScientificCGJClass I
K822226Erika Negative Pressure Venous Blood LinErika, Inc.KOCClass II
K822225Erika Negat. Pressure Arter. Blood LineErika, Inc.KOCClass II
K822224Empi Single UseEmpiGXYClass II
K822216Volumetric ControllerQuest Medical, IncBTCClass I
K822211Sterile Hd Pan SetHospital Disposables, Inc.FRGClass II
K822206Total Ige DiscsKallestad Laboratories, Inc.DGCClass II
K822197Needle HoldersKelleher Corp.LCRClass II
K822190ENT ElevatorsKelleher Corp.KADClass I
K822189Beckman Adenoid CurretteKelleher Corp.KBJClass I
K822184ENT Metal Tongue DepressorsKelleher Corp.KBLClass I
K822183Mouth GagsKelleher Corp.KBNClass I