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 3301 of 3528
510(k) clearances, page 3301 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K810857T3 Uptake KitImmuno Assay Corp.KHQClass II
K810852Follicle Stimulating Hormone AntiserumPcl-Ria, Inc.CGJClass I
K810833Sorvall Rt6000 Refrigerated TabletopE.I. Dupont de Nemours & Co., Inc.JQCClass I
K810829AcrodiscGelman Sciences, Inc.JRLClass I
K810818Key-Med Fibrescope Disinfection TrolleyKeymed, Inc.FEBClass II
K810757i.v. Administration SetAmerican McgawFDAClass II
K810684Hemocolor Stain SetHarlecoICCClass I
K810657Temptron #'S 6804/6805Medtronic, Inc.LDFClass II
K810643Universal Pacing Electrode KitStanco Medical, Inc.LDFClass II
K810642Atrial-Ventricular Pacing Electrode KitStanco Medical, Inc.LDFClass II
K810550Silver AnodeNobel Scientific Industries, Inc.JFSClass II
K810549Thermal Printer PaperNobel Scientific Industries, Inc.JJEClass I
K810502Scrippsystem C4 Rid KitScripps-Miles, Inc.DBIClass II
K810501Scrippsystem C3 Rid KitScripps-Miles, Inc.CZWClass II
K810478Animal Serum ProductsAnimal Health Laboratories, Inc.KISClass I
K810329Depuy Segmentalspinal SystemDepuy, Inc.KWPClass II
K810328Bio Condylar Tm KneeDepuy, Inc.JWHClass II
K810037Dental Chewing Gum (Sugarless)Mcdennan Oral Products, Inc.EJRClass I
K803302Preheparinzed SyringeThe University of ChicagoFMFClass II
K810816Prefilled Arterial Blood Sampling SyringCurrent Technologies, Inc.JKAClass II
K810811T4 Ria KitImmuno Assay Corp.CDXClass II
K810807Holliseal Ostomy Skin BarrierHollister, Inc.EXBClass I
K810798Technicon Star System T3 Ria MethodTechnicon Instruments Corp.CDPClass II
K810710Hollister Skin Barrier BHollister, Inc.EXBClass I
K810709Hollister Skin Barrier aHollister, Inc.EXBClass I
K810617Mobile Matic Automatic Donor ScaleLifeline Instruments, Inc.KSQClass I
K810540Knee ProsthesisCintor Orthopaedic Div.HRYClass II
K810506Propper Sigmoidoscope Suction InstrumentPropper Mfg Co IncOCXClass II
K810250Tray, IrrigationMegaplast, Inc.KNTClass II
K810249Tray, Catherization, UrethralMegaplast, Inc.KODClass II
K810060P.c.a. Total Knee Stemmed Tibia ProsthHowmedica Corp.HRYClass II
K802170Suru Blood Collection SetSuru Chemicals & Pharmaceuticals, Ltd.FPAClass II
K802169Suru Infusion Set Type JSuru Chemicals & Pharmaceuticals, Ltd.FPAClass II
K810838Neonatal Blood Pressure CuffInvivo Research Labs, Inc.DXQClass II
K810820Cardiopulmonary BypassDlp, Inc.DWFClass II
K810799Quantimune Ferritin IrmaBio-RadJMGClass II
K810762Api Turbicity StandardAnalytical Products, Inc.JKPClass I
K810755Squinn Vitatek 500 Series Physiol. MoniVitatekDRTClass II
K810728Tab Pediatric CribCambridge ScientificFMSClass II
K810720I.m. Scalpel HandleInstrument Makar, Inc.GDZClass I
K810682Pentax Colonoscope Model Fc-34LaPentax Precision Instrument Corp.FDFClass II
K810647Shiley Oxygenator Thermistor ProbeShiley, Inc.DWCClass II
K810628Electrosurgical Cutting & CoagulationIntermedics, Inc.JOSClass II
K810613Antimicrobial Removal DeviceMarion Laboratories, Inc.MDBClass I
K810602Emit-St Serum Barbiturate AssaySyva Co.DISClass II
K810526Rich-Mar Hv II Select-a-PulseRich-Mar Corp.IMGClass II
K810503Flexible Choledochoscope/nephroscopeOlympus Corp.NWSClass II
K810278Eyeglass FramesCaesar Intl. DesignsHQZClass I
K810182Programmable Spinal Coral Stim. SystemElectronic Diagnostics, Inc.GZBClass II
K810138Synap-I Infant Sensory Assessment UnitInfant Hearing Assessment FoundationGWJClass II