510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3068 of 3528
510(k) clearances, page 3068 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K842011Chloride Test KitMallinckrodt Critical CareCHJClass II
K842002Hanks Balanced Salts-Hbss H2387Sigma Chemical Co.KITClass I
K842000Primary Rabbitt Kidney Cell CultureBartels Immunodiagnostic Supplies, Inc.KIRClass I
K841999Bgm Cell Culture African Green MonkeyBartels Immunodiagnostic Supplies, Inc.KIRClass I
K841916Abbott Project IAbbott MedicalJJEClass I
K841887Paramax Iron Blank ReagentAmerican DadeJIYClass I
K841886Paramax Iron ReagentAmerican DadeJIYClass I
K841875Heart-Check ECG TransmitterPhysio Ventures, Inc.
K841854Bhcg RiaSyncor Intl. Corp.JHIClass II
K841853Preg-Beta One Hour Tube TestIntl. Diagnostic, Inc.JHJClass II
K841821Ca-1511, in Vitro RadioimmunoassayTravenol Laboratories, S.A.JHIClass II
K841816Optimate Igg TestMiles Laboratories, Inc.DEWClass II
K841814Optimate Igm TestMiles Laboratories, Inc.DFTClass II
K841801Denture CleanserMiracle Clean, Inc.EFTClass I
K841776Ana Sensitivity/specificity ControlBehring Diagnostics, Inc.DHNClass II
K841551Osseointegrated Fixtures-Tissue IntegrBofors Nobelpharma, Inc.DZEClass II
K841550Scotchbond Light Cured Dental Adhes3M CompanyEBFClass II
K841475Hearing Aid Model M400Radioear Corp.ESDClass I
K841474Hearing Aid Model P500Radioear Corp.ESDClass I
K841473Hearing Aid Model 440PpcRadioear Corp.ESDClass I
K841464Changes in the Chemical Comp. of 5Nova Biomedical CorporationJIXClass II
K841452Nova Stat Control Levels 1/2/3Nova Biomedical CorporationJJYClass I
K841424Electrolyte Analyzer Sera-210Horiba Instruments IncorporatedJGSClass II
K841302Diagnon Folate 125I Ria KitDiagnon Corp.CGNClass II
K841187Blood Collection Set, Sterile, Dispos.Marbex, Inc.BRZClass II
K840962Reflocheck-SBoehringer Mannheim Corp.CGAClass II
K840484Diatron Easytest Blood Glucose MoniMedivix, Inc.CGAClass II
K840023Trantec Physiological Pressure TransducAmerican BentleyDRSClass II
K834457Emit D.a.u. Urine Cannabinoid CalibraSyva Co.DLJClass II
K834226Flame PhotometersDr. Bruno Lange GmbHJJOClass I
K833875Shea Footplate MicrodrillApplied Research Corp.ERLClass II
K833874Shea Middle Ear MicrodrillApplied Research Corp.ERLClass II
K833486In-the-Ear Hearing Aid ModelDanavox, Inc.ESDClass I
K833275GMP Ciq Elisa Test KitGamma Medical Products, Inc.DAKClass II
K831176Filtryzer Hollow Fiber Artif. KidneyErika, Inc.KOCClass II
K831175Filtryzer Hollow Fiber Artif. KidneyErika, Inc.KOCClass II
K831174Filtryzer Hollow Fiber Artificial Kid-Erika, Inc.KOCClass II
K831173Toray Industries Filtryzer Hollow FiberErika, Inc.KOCClass II
K841238Emit St Urine Cannabinoid AssaySyva Co.LDJClass II
K834458Emit D.a.u. Urine Cannabinoid AssaySyva Co.LDJClass II
K842256As Latex PlusBiokit USA, Inc.GTQClass I
K842111Kogan Endospeculum 9-1/2J. Sklar Mfg. Co., Inc.HTZClass I
K842098Rim H2sAustin Biological LaboratoriesJSFClass I
K842045Woodlyn Classic Exam. ChairWoodlyn, Inc.HMEClass I
K841982Meniscotome 4Mm & 5MmStainless Mfg., Inc.HTZClass I
K8419814Mm & 5Mm FileStainless Mfg., Inc.HTPClass I
K8419794Mm Cup CurretteStainless Mfg., Inc.HTFClass I
K841978Lateral Release Knife 5Mm & 7MmStainless Mfg., Inc.HTZClass I
K8419775Mm Dougle Edge Ring CuretteStainless Mfg., Inc.HTZClass I
K841976Hook Knife 4Mm & 5MmStainless Mfg., Inc.HTZClass I