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 3167 of 3528
510(k) clearances, page 3167 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830769Fekal Con-Trate SystemTrend Scientific, Inc.KLIClass II
K830727Cardiotomy Reservoir-Filtered & NonElectromics, Inc.DTPClass II
K830693Dupont Prep Type as Extraction CartrideE.I. Dupont de Nemours & Co., Inc.DJYClass I
K830692Dupont Prep Od Extraction CartrideE.I. Dupont de Nemours & Co., Inc.DJYClass I
K830672Creatine Kinase Reagent SetSterling Biochemical, Inc.JHYClass II
K830668Fiax Complement C3 Test KitIntl. Diagnostic TechnologyCZWClass II
K830642Phase Thyroxine Radioimmunoassay KitMedical & Scientific Designs, Inc.CDXClass II
K830641Encore Chemistry AnalyzerBaker Instructions Corp.JJGClass I
K830636Potassium DiluentShaban Mfg. Co.JIHClass II
K830624Fluorometer, General UseAbbott DiagnosticsKHOClass I
K830616Activated Uric AcidAmerican Monitor Corp.CHDClass I
K830590Corning 2500 Co-OximeterCorning Medical & ScientificKHGClass II
K830533Phase II Digoxin Radioimmunoassay KitMedical & Scientific Designs, Inc.DONClass II
K830526B-Gcg System by RiaPcl-Ria, Inc.JHIClass II
K830518Emit-St Photometer & Diluter VerificaSyva Co.DIFClass I
K830512Leeco Testosterone Diagnostic KitLeeco Diagnostics, Inc.CDZClass I
K830497Pem-THedecoJWZClass I
K830495Polystyrene Microtiter Plate ImmunosorDiagnostic Reagent Tech.DGOClass II
K830474IV StandTeknar, Inc.HQCClass II
K830413Handpiece System I/aUxtra Corp.HQZClass I
K830412Radioimmunoassay Test System PrlMonobind, Inc.CFTClass I
K830385Irrigation/aspiration KitVxtra Corp.HQCClass II
K830379Phako KitVxtra Corp.HQCClass II
K830331Liquid Thromboplastin ReagentHelena Laboratories, Corp.GJSClass II
K830320Activat-Partial Thrombo-PlastinHelena Laboratories, Corp.GGWClass II
K830286Yeast IdentAnalytical Products, Inc.JXBClass I
K830241Ultra Chem Bun-UV #65080-65081EMD Millipore CorporationCDQClass II
K830239Ultra Chem Enzymatic Cholesterol OxidaEMD Millipore CorporationCHHClass I
K830213Nova 7 Total Calcium/ionized CalciumNova Biomedical CorporationJFPClass II
K830212Elisa Plus SystemWilliam-Palmer Industries, Inc.JJEClass I
K823421Phadebas Humylase Control(h)Pharmacia, Inc.JJXClass I
K822095Herpes-Iha KitHillcrest BiologicalsKLCClass I
K837235Model 920 Argon Laser SystemCoherent Radiation Laboratories
K837216Model Xa-15 Laser System for SurgeryXanar, Inc.
K837213Multi-User Imaging and Acquisition TerminalsComputer Design & Applications, Inc.
K837200Britt Surgical Photocoagulator SystemBritt Corp., Inc.
K837063Biosound Surgiscan, Ultrasound Imaging SystemBiosound, Inc.
K828574Novo Bmc Lab 22A Bone Mineral Content Determination in the Axial SkeletonNovo Diagnostic Systems
K830009OxymizerChad Therapeutics, Inc.NFBClass II
K837181Eminex Ls-8 SystemElscint, Inc.
K837046Autofocus Probe for Use with Ultrasound Autosector SystemTechnicare Corp.
K830781Endo-GuardJayco PharmaceuticalsFOGClass I
K830767Williams Airway IntubatorWilliams Airway IntubatorCAEClass I
K830765Winged CatheterAbbott MedicalFOZClass II
K830696Venes Anti Embolism StockingsFuturo Div. Jung Corp.DWLClass II
K830691PrimeAnsell, Inc.HISClass II
K830688Combion Skin TestNicholas H. MaganiasLKHClass I
K830605Pump Pall Ambulatory Insulin InfusionBiomedical Devices, Inc.FRNClass II
K830575Renalin (TentativeRenal Systems, Inc.LIFClass II
K830557Erg-Jet ElectrodeUniverso S.A.HLZClass II