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 3225 of 3528
510(k) clearances, page 3225 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821426Staphylococcus Medium 1100Interstate MediaJSIClass I
K821425Columbia Blood Agar W/5% Sheep BloodInterstate MediaJSHClass I
K821424Tryptic Soy Agar W/5% Sheep BloodInterstate MediaJSHClass I
K821423Macconkey AgarInterstate MediaJSIClass I
K821422Ss AgarInterstate MediaJSIClass I
K821421Hektoen Enteric AgarInterstate MediaJSIClass I
K821420Emb AgarInterstate MediaJSIClass I
K821419Emb AgarInterstate MediaJSIClass I
K821418Tryptose Blood Agar W/5% Sheep BloodInterstate MediaJSHClass I
K821417Tryptic Soy Agar W/10% Sheep BloodInterstate MediaJSHClass I
K821375Deodorant Sure & Natural MaxishieldsPersonal Products Co.HHLClass II
K821302#50003 Quad Diagnostic SystemBiomedia, Inc.JSHClass I
K821301#50002 Quad Diagnostic SystemBiomedia, Inc.JSIClass I
K821266Bbl Directigen Meningitis Test KitBD Becton Dickinson Vacutainer Systems PreanalyticGRPClass II
K821241Free T4 Radioimmunoassay KitBioclinical GroupCECClass II
K821005Platelet Aggregation Profiler #Pap-4Bio/Data Corp.JBXClass II
K820857Safe-T-SealWisconsin Scientific Corp.GEIClass II
K820854Kenz-45MSuzuken Co., Ltd.DXNClass II
K820725Spac T4 Ria Test KitMallinckrodt Critical CareCDXClass II
K821537Henke Disposable SyringeC. B. Dumont Company, Inc.FMFClass II
K821530Syringe IrrigatingMedcare Disp Products, Inc.KYZClass I
K821516Tracker-2 Channel ECG Tape RecorderReynolds Medical, Ltd.DSHClass II
K821488Elecath Portal Vein/biliary Drain AssmElectro-Catheter Corp.KNNClass I
K821459Ultrazyme Plus Amyl #65031&64982EMD Millipore CorporationJFJClass II
K821452Durazyme CpkAmerican Monitor Corp.
K821437Digital Blood Pressure MeterTimex Medical Products Corp.DXNClass II
K821413Emit C-Reactive Protein AssaySyva Co.DCNClass II
K821399Macro-Vue Card Test, NetilmicinBD Becton Dickinson Vacutainer Systems PreanalyticLCEClass II
K821385Sero/tex Le TestTexas Immunology, Inc.DHCClass II
K821382Chemistry Control/standardMedical Analysis Systems, Inc.JJYClass I
K821379Emit-Tox Acetaminophen AssaySyva Co.LDPClass II
K821374Enzymune-Test InsulinIcl ScientificCFPClass I
K821367Gf-180-M & Gf-180-H HemodialyzersGambro, Inc.KOCClass II
K821364Proflex Flexible ScalerTeledyne DenscoEHMClass I
K821363Trans-QChesapeake Medical Assoc.GZJClass II
K821358Modified Rongeurs for Spinal & Orth. S.Downs Surgical, Ltd.EMHClass I
K821347Bio-Mag Theophylline (125I) Radioimmun.Bioclinical Corp.LCAClass II
K821346Quantimune Hlh RiaBio-RadCEPClass I
K821344Engstrom Metabolic ComputerLkb Instruments, Inc.BZLClass II
K821338Salmonella I.d.Analytical Products, Inc.GRMClass II
K821337Shigella I.d.Analytical Products, Inc.GNBClass II
K821326Cutter Bond Polycarboxylate CementCutter Laboratories, Inc.EMAClass II
K821317Universal i.v. HolderGeorgetown Medical Co.KMKClass I
K821314Fever MeterSteridyne Corp.KDPClass II
K821312Temptrend Temperature Trend IndicatorLiquid Crystal Products, Inc.KPDClass II
K821299Cer-MateJ. Aderer, Inc.EJSClass II
K821298Backhaus Clamp, 3 1/2Conphar, Inc.HTDClass I
K821294Tonsil Scissors Straight 5 1/2Conphar, Inc.EGNClass I
K821293Backhaus Clamp, 5 1/4Conphar, Inc.HTDClass I
K821292Tonsil Scissors 7Conphar, Inc.EGNClass I