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 3087 of 3528
510(k) clearances, page 3087 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840553HemastaphRemel Co.JTLClass I
K840496Isostat Microbial Tube ProcessingE.I. Dupont de Nemours & Co., Inc.JKAClass II
K840457Normal Clinical Chem. Control Serum-Otisville Biotech, Inc.JJYClass I
K840456Sun-Lite 1Suncoast Medical Manufacturers, Inc.
K840429Sun-Lite One MillimeterSuncoast Medical Manufacturers, Inc.
K840412Ovu Stick Urine Hlh KitMonoclonal Antibodies, Inc.CEPClass I
K840334Chemonucleolysis/discography TrayApplied Medical Devices, Inc.FMIClass II
K840284Multiple Sys-Urine Drainage-ClosedLuth Corp.KNXClass II
K840283Multiple Bag, LegLuth Corp.KNXClass II
K840255Vistech Vcts 6000Vistech Consultants, Inc.HOXClass I
K840176Estic MicrofillKulzer GmbHEBFClass II
K840118RhinothermAscot Pharmaceuticals, Inc.KFZClass I
K834587Hemodial ConcentrateMoana Productions, Inc.FKQClass II
K834505Human Serum Electrolyte Control-LiquidQuantimetrix Corp.JJRClass I
K834486Technicare 280Technicare Corp.IYOClass II
K834274Criterion ITimeter Instrument Corp.CAWClass II
K833983Provider U-100 Insulin Infusion SysPancretec, Inc.FRNClass II
K833711Thermo Sentry 1200 Thermo-Sys-Ts1200Clini-Therm Corp.FLLClass II
K833396C-Peptide Radioimmunoassay Test KitSerono Diagnostics, Inc.JKDClass I
K8338303-Day Bioindicator Release Process forShiley, Inc.DWFClass II
K841506Meta-3Whale Scientific, Inc.
K834432Anthro-Modular Total KneeZimmer GmbHJWHClass II
K841489Norelco Electronic Digital Bp MeterNorth American Philips Corp.
K841441Sera-250Horiba Instruments Incorporated
K840232Abm Anesthesia & Brain MonitorDatex Division Instrumentarium Corp.
K840119Continuous VentilatorBear Medical Systems, Inc.CBKClass II
K841240Disposable Anesthesia MaskHospitak, Inc.BSJClass I
K841236Filter-FlexLife Design Systems, Inc.CAHClass II
K841218Cycloserine-Cefoxitin Fructose AgarAnaerobe SystemsJSIClass I
K841211Selective BrothSmith River BiologicalsJSDClass I
K841208Propagating TransportSmith River BiologicalsJSNClass I
K841142Levine Eosin Methylene Blue AgarAnaerobe SystemsJSIClass I
K841120Res-Q-MateRsq Industries, Inc.CAEClass I
K841028Provider Cap SetPancretec, Inc.FPAClass II
K841018Pancretec Pump CheckPancretec, Inc.FRNClass II
K840987Vaporized HeparinConcord Laboratories, Inc.CBTClass I
K840986Prefilled Pulsator SyringeConcord Laboratories, Inc.CBTClass I
K840974Somas Human Spinal Fluid ControlSomas Medical Industries, Inc.DFIClass I
K840935Manual Resuscitation SystemInspiron Corp.BTMClass II
K840921Therachem Tdc Therapeutic Drug ControlFisher DiagnosticsDIFClass I
K840822Leap Mono Test KitCooper Biomedical, Inc.KTNClass II
K840821Trns Mi 8202Medical Scientific InstrumentsGZJClass II
K840789Bitestick BlockCherry Plastics, Inc.JXLClass II
K840785Paramax Urea Nitrogen ReagentAmerican DadeCDQClass II
K840780Triglycerides ReagentAmerican DadeCDTClass I
K840777Direct Bilirubin ReagentAmerican DadeCIGClass II
K840760Harvard Anti-Reflux Y-SetC.R. Bard IncFPAClass II
K840645Engstrom Eliza Duo CO2 & O2 AnalyzGambro, Inc.CCLClass II
K840475Cystotome, 140-SCilco, Inc.HNYClass I
K840420Airway Pressure MonitorRespiratory Support Products, Inc.CAPClass II