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 3195 of 3528
510(k) clearances, page 3195 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823036Autoclave Testing Adhesive TapeIndustrias Tuk, S.A. de C.V.JOJClass II
K823034Syva Advance Thyroxine AssaySyva Co.KLIClass II
K823011Vc IIITeknar, Inc.EPTClass I
K822963Surgical Products, Skin Staple RemoverTemp-Stik Corp.FZQClass I
K822900Fisch Drill PumpTeknar, Inc.
K822324Red Cell Lysing Reagent 78N 1915-1Interscience, Inc.GGKClass I
K822086Dia-SpecExitec, Inc.HIBClass II
K823156Collapsable Lavatory HeightenerOrthion Corp.ILSClass I
K823155Lavatory Seat HeightenerOrthion Corp.ILSClass I
K823154Shower Stool W/handlesOrthion Corp.IKXClass I
K823153Bath Tub Seat & Bath BoardOrthion Corp.IKXClass I
K823152Ob Help ArmOrthion Corp.ILEClass I
K823151Ob Tripp Transport ChairOrthion Corp.INMClass I
K823150Sesam Treatment TableOrthion Corp.INQClass I
K823149Ob Tilt TableOrthion Corp.INWClass I
K823114Brace-Up Stocking Knee BraceArco Matic, Inc.IQIClass I
K823105Resi-WalkerOrthion Corp.ITJClass I
K823091H BrothGranite Diagnostics, Inc.JSHClass I
K823072Lecithin Lactose AgarGranite Diagnostics, Inc.JSEClass I
K823071Rice Extract AgarGranite Diagnostics, Inc.JSHClass I
K823070Acetamide Agar SlantGranite Diagnostics, Inc.JSHClass I
K823061Brush, Scrub, Operating RoomSeamless Hospital Products Co.GECClass I
K823055Flouroset Immunofluorescent AntibodyImmulok, Inc.DHNClass II
K823046Km-Kal L5Kmn Products, Inc.JIXClass II
K823045Km-Kal L4Kmn Products, Inc.JIXClass II
K823043Km-Kal L2Kmn Products, Inc.JIXClass II
K823042Km-Kal L1Kmn Products, Inc.JIXClass II
K823009Gamma ClqGamma Medical Products, Inc.DAKClass II
K823004Bio Mag Total T4 Radioimmunoassay KitBioclinical GroupCDXClass II
K822988Coagulase Plasma-Citrated & EdtaAmerican Scientific ProductsJTLClass I
K822987Dressing SpongeHermitage Hospital Products, Inc.NABClass I
K822966Convertors Disposable Dressing SpongeAmerican Hospital SupplyNABClass I
K822958Lancer Msh Glucose Diag. KitSherwood Medical Co.CGAClass II
K822938Phadebase Humylase ControlPharmacia, Inc.JJXClass I
K822937Glucose/urea Nitrogen StandardEMD Millipore CorporationJIXClass II
K822932Emit Clinical Processor #Cp-5000Syva Co.JQPClass I
K822882Coat-a-Count Free Thyroxine Kit/componenSiemens Healthcare Diagnostics Inc.CECClass II
K822855Yersinia Isolation MediumGranite Diagnostics, Inc.JSIClass I
K822784Hemo-DePmp IndustriesKEMClass I
K822728Solid Phase Simul Trac Vitamin B12BD Becton Dickinson Vacutainer Systems PreanalyticCGNClass II
K822699Glucoscan Meter Model IILifescan, Inc.CGAClass II
K822688Digital Diluter/dispensersHamilton CoJQWClass I
K822486Home Blood Glucose MonitorPharmaquest Corp.CGAClass II
K827489Hyperlux 30 Image SystemCgr Medical Corp.JAAClass II
K823006Medevices Aspiration HoseBerkeley MedevicesHHKClass II
K822969Generation 5 Linkow Blade ImplantsLeonard P. Linkow, D.D.L.NRQClass II
K822819Trimed 510 Apnea MonitorTri-Med, Inc.BZQClass II
K823056The Inglefield Magic RingThe Inglefield Co.FMFClass II
K823008NovarexJeneric Ind.EJHClass II
K822989Harvard Apparatus Single Speed SyringeC.R. Bard IncFRNClass II