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 3465 of 3526
510(k) clearances, page 3465 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K771574Lee Aspiration NeedleRadiation Development Co., Inc.GDMClass I
K771320Cryosurgical EquipmentA.S.M.O.T.GEHClass II
K772198CT Scanner Diagnostic Console, RemoteVarian Assoc., Inc.JAKClass II
K772140Scanning Sys., Auto. Comp., Acs1000Honeywell, Inc.JOYClass II
K772193Nassal Pressure/flow RecorderAdco Labs.ETL
K772169Audiometer, Recording, AutomaticB&K Instruments, Inc.EWOClass II
K772164Panoramic X-Ray System Model aSybron Corp.EHDClass II
K771874J-Vac Vacuum TubeJelco LaboratoriesGIMClass II
K772185Laparoscope W/removable OpticsKliHETClass II
K772168MoldeyeRobert B. Scott Ocularists of Florida, Inc.HQNClass II
K772154Cervical Traction Div., PneumaticJobstITHClass II
K772151Urinary Vma - Screen Test KitEppendorf-Brinkmann, Inc.CDFClass I
K772114Fiax C4 AssayIdt, A Division of Whittaker M.A. BioproductsDAKClass II
K772105Platelet KitStreck Laboratories, Inc.GLGClass I
K771990Omnimedical 400LOmnimedical Services, Inc.JAKClass II
K771875Ultrafiltration Monitor 5M9034Travenol Laboratories, S.A.FILClass II
K771784Iopsy Tray for Soft Tissue BiopsyBD Becton Dickinson Vacutainer Systems PreanalyticGAAClass I
K771511Total Knee Prosthesis-Nonconstrained3M CompanyHSXClass II
K772148Catheter, Femoral Vein, Sf 6Sorensen ResearchFJTClass II
K772146Catheter, Vein, Femoral, Sf 10Sorensen ResearchFJTClass II
K771785Irrigating Needle, IlluminatedConcept, Inc.
K771639Electrosurgical GeneratorCameron-Miller, Inc.GEIClass II
K771022Catheter, Umbilicar ArteryAxiom Medical, Inc.FOSClass II
K772175Catheter System, Cope/eisenbergVictory Engineering Corp.DQOClass II
K772165Spectrophotometer - Series Aa-575Varian Assoc., Inc.JXRClass I
K772163Dialysis Machines Dm-346 & 346-1Extracorporeal Medical Specialities, Inc.FIJClass II
K772160Electrosurgical Grounding PadNdm Corp.JOSClass II
K772152Central Monitoring SystemBurdick Corp.DXGClass II
K772150Dialysis Drainage Unit, PeritonealC.R. Bard IncFKXClass II
K772147Gw 35 Guide WireSorensen ResearchFIFClass II
K772144Catheter, Disp., External, MaleMEDLINE INDUSTRIES, LP - NorthfieldEXJClass I
K772134Syringe, Irrigation, Pre-FilledKendall Research CenterKOAClass I
K772133Urine Specimen Collecting DeviceKendall Research CenterFCNClass II
K772130Ocular Cerebral Vascular MonitorDigilab, Inc.HKYClass II
K772111In Vitro Phenobarbital Ria TestClinical Assays, Inc.DKPClass II
K772107Creatinine Urine Appli.-#32308HarlecoCGXClass II
K772104Pacing Lead Model 6991AMedtronic, Inc.DTBClass III
K772082Enzac Uric Acid 100-Test KitBD Becton Dickinson Vacutainer Systems PreanalyticCDHClass I
K772065Critical Care Ventilator 2Ohio Medical ProductsCBKClass II
K772043Alpha/cholStandard Scientific, Inc.CGOClass I
K772040Transducer ProtectorTerumo America, Inc.FKJClass II
K772010Cardiac Pacemaker C2001Vitatron Medical BVDXYClass III
K772009Cardiac Pacemaker S6001Vitatron Medical BVDXYClass III
K772006Acute Cardiac Care SystemPhysio Control, Inc.DRTClass II
K771924HeartbeaterDunn Instruments, Inc.DXGClass II
K771865Daystar Surg. Light 9100 & Orbiter 9110Castle Co.FSYClass II
K771861Catheter, Cebtral Venous, 2N1501Travenol Laboratories, S.A.JCYClass I
K771807Spectrophotometer Analysis Sys.Varian Assoc., Inc.JJQClass I
K771753Hematology Reference ControlCoulter Electronics, Inc.JPKClass II
K771680Armor-Kot Surgical InstrumentsStorz Instrument Co.FSMClass I