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 3072 of 3528
510(k) clearances, page 3072 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841766Woodlyn Classic Trial Lens SetWoodlyn, Inc.HPCClass I
K841759Ophthalmic TableWoodlyn, Inc.HMGClass I
K841734Tago Fiffu-Gen, OrosomucoidTago, Inc.LKLClass I
K841729Accupro Enteral Feeding PumpAmerican McgawFRNClass II
K841652Ocular Pressure ApplicatorThe Lebanon Corp.
K841651Vast Ventrex Rast AllVentrex Laboratories, Inc.DGCClass II
K841541Serum Complement Activity Test-ScatCollaborative Research, Inc.DAKClass II
K841523Owren's Veronal BufferrDiatech, Inc.JPAClass II
K841462Heparin Coagulation Control Plasma 1-Diatech, Inc.JPAClass II
K841366Dia FibrinDiatech, Inc.KQJClass II
K841365Dia ReptinDiatech, Inc.GIRClass I
K841163Contact Lens Inserter/removerOptimum Manufacturers, Inc.HQDClass II
K840864Gore-Tex CatheterW. L. Gore & Associates, Inc.KNTClass II
K840525Servomed Compact Monitor Smk 155-1/101Litton Medical ElectronicsDRTClass II
K840521Servomed Digital Display ModuleLitton Medical ElectronicsDRTClass II
K840115Swiss Optical Products-Contact CaseMoonbeam International, Inc.HQDClass II
K834600Recomb ECG Preamplifier/206 069 03Litton Medical ElectronicsDRTClass II
K834530Extension Box Eb200Honeywell, Inc.DRTClass II
K833000I-Channel RecorderLitton Medical ElectronicsDSFClass I
K8329982-Channel RecorderLitton Medical ElectronicsDSFClass I
K832250Servomed Basic Bedside Unit Sma 102-Litton Medical ElectronicsDRTClass II
K841952Multi-Purpose Task Support TableNeutral Pos-Chair Co.
K841874Mega Pulse Therapy UnitPhysio Technology, Inc.IMJClass II
K841866Innoflour TobramycinInnotron DiagnosticsLFWClass II
K841865Innoflour GentamicinInnotron DiagnosticsLCQClass II
K841848Retic-SetR & D Systems, Inc.KQCClass I
K841845Selective Culture Med. Columbia CnaMicroline ScientificJSJClass I
K841844Differential Culture Medium-Biggy AgarMicroline ScientificJSIClass I
K841843Differential Culture Med. Levine EmbMicroline ScientificJSHClass I
K841842Differential Culture Med. Macconkey AgarMicroline ScientificJSIClass I
K841804Elvi 70 Safety ChamberLogos Scientific, Inc.JJNClass I
K841800Lysing & Hemoglobin ReagentReagent Laboratory, Inc.GGKClass I
K841799Cyanomethemoglobin ReagentReagent Laboratory, Inc.GIFClass I
K841751Levine Eosin Methylene Blue AgarThe Montana Deaconess Medical CenterJSIClass I
K841750Martin-Lewis AgarThe Montana Deaconess Medical CenterJTYClass II
K841749Chocolate AgarThe Montana Deaconess Medical CenterKZIClass I
K841748Sheep Blood AgarThe Montana Deaconess Medical CenterKZIClass I
K841746Salmonella-Shigella AgarThe Montana Deaconess Medical CenterJSJClass I
K841715Kyotest UK Urine Test Reagent StripKyoto Diagnostics, Inc.JINClass I
K841714Kyotest 2V, Urine Test Reagent StripKyoto Diagnostics, Inc.JILClass II
K841713Kyotest Ug Urine Test Reagent StripKyoto Diagnostics, Inc.JILClass II
K841702Tdx Rea Uric AcidAbbott MedicalKNKClass I
K841595Healthcheck Home Pregnancy Test KitTimex Medical Products Corp.LCXClass II
K841586Chocolate AgarMicroline ScientificKZIClass I
K841537Impact Model 601ZOLL Medical CorporationBTIClass II
K841534Acme Digital Infant Scale-30Acme Medical Scale Co.FRWClass I
K841160Morwel AspiratorMorwel Corp.JCXClass II
K840976Various Disposable Kits/trays/instruCarapace, Inc.FSMClass I
K833688Suture Removal Kits SterileCarwild Corp.KGXClass I
K842157Triglyceride Assay Kit-ColorimetricDiagnostic Chemicals, Ltd. (USA)