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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
46,132 of the 176,529 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
20262,732
176,529 records, page 2174 of 3531
510(k) clearances, page 2174 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K935298Insta-Nerve(tm) Nerve Conduction MonitorInsta Nerve Canada, Inc.JXEClass II
K943443SunglassesSunny Union Industrial Co., Ltd.HQYClass I
K943442Spectacle FramesSunny Union Industrial Co., Ltd.HQZClass I
K943236Optiline, Carlo Bellini, Exploreflex, Stratford & TitiniflexOptiline Imports and Trade, Inc.HQZClass I
K943131Orvis Polarized Bi-FocalsThe Orvis Co., Inc.HQYClass I
K943086Spectacle FrameRadiant Spectacles ManufacturersHQZClass I
K943083Spectacle FramePimex Co., Ltd.HQZClass I
K943074Forceps, Punches, ScissorsKarl Storz Endoscopy-America, Inc.EOBClass II
K943024Kinase IsoenzymeDupont Medical ProductsJHSClass II
K942951Orvis Light Weight Polarized Clip-OnsThe Orvis Co., Inc.HQYClass I
K942807Surgical Lift SheetSurgin Surgical Instrumentation, Inc.FSAClass I
K942161LockboxPharmacia Deltec, Inc.FRNClass II
K942150Cvd Small Vessel Balloon Dilation CatheterCardio-Dynamics, Inc.LITClass II
K941929SunglassesTop Champ, Inc.HQYClass I
K941540SunglassesTonview International Co., Ltd.HQYClass I
K941532Biocalex 6/9Bio-Probe, Inc.EJKClass II
K941433Hi Chem Aqueous Glucose Control, Low, Med, HighHichem DiagnosticsJJXClass I
K941272KleenspecWelch Allyn IncHIBClass II
K941111Strep-Sure A/eClinical Standards Laboratories, Inc.JTOClass I
K940953Umbili-Cath-SGesco Intl., Inc.FOSClass II
K940905Microtainer Brand Tube with Edta(k2)BD Becton Dickinson Vacutainer Systems PreanalyticJKAClass II
K940870Umbili-CathGesco Intl., Inc.FOSClass II
K940864Dentist with Assistant PackSterile Concepts, Inc.EIAClass I
K940271Incstar Acth IrmaIncstar Corp.CKGClass II
K940167Diagnostic I CatheterEp Technologies, Inc.DRFClass II
K936121Thairapy SystemAmerican Biosystems, Inc.BYIClass II
K935370Miniox Ia Oxygen AnalyzerMinesafety Appliances Co.CAWClass II
K933549Vidas Cmv Igm AssayBiomerieux Vitek, Inc.LKQClass II
K932556Ammonia Assay Cat. No. 200-02Diagnostic Chemicals, Ltd. (USA)JIFClass I
K925819Akcess0cath KitAkcess Medical Products, Inc.LFJClass II
K925766Branemark System Temporary SolutionsNobelpharma USA, Inc.DZEClass II
K943273Tri Hawk Bur, Fg BurTri Hawk Corp.EJLClass I
K943271Solder #206Argen Precious Metals, Inc.EJTClass II
K943269Solder #209Argen Precious Metals, Inc.EJTClass II
K943267Solder #211Argen Precious Metals, Inc.EJTClass II
K943266Solder #210Argen Precious Metals, Inc.EJTClass II
K943264Solder #205Argen Precious Metals, Inc.EJTClass II
K943214Solder #204Argen Precious Metals, Inc.EJTClass II
K943213Argiplus LoArgen Precious Metals, Inc.EJTClass II
K943212Argesol #830YArgen Precious Metals, Inc.EJTClass II
K943211Argesol 750YArgen Precious Metals, Inc.EJTClass II
K943210Argesol #1005YArgen Precious Metals, Inc.EJTClass II
K943209Argesol PnpArgen Precious Metals, Inc.EJTClass II
K943208Argesol 750PyArgen Precious Metals, Inc.EJTClass II
K943151Powder-Free Latex Examination GlovesShield Gloves Medical Products Sdn BhdLYYClass I
K942940Royal Shield Powder-Free Latex Examanation GlovesShield Gloves Manufacturer (M) Sdn BhdLYYClass I
K942812Flo-Rester Disposable Vessel OccluderBio-Vascular, Inc.DXCClass II
K942795Cedia Dau Benzodiazepine AssayMicrogenics CorporationJXMClass II
K942757Asherman Chest BandageAsherman Medical Products, LLCMGPUnclassified
K942337Cedia Dau Multi-Level Thc AssayMicrogenics CorporationLDJClass II