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 3077 of 3528
510(k) clearances, page 3077 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841420Sodium & Potassium Standard Sol 80Reagent Laboratory, Inc.JIXClass II
K841419Sodium & Potassium Standard SolutReagent Laboratory, Inc.JIXClass II
K841377Creatinine - A.a.s.Advanced Analytical Systems, Inc.CGXClass II
K841346Ultraclone Ecl-01-200 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841345Ultraclone Ecl-01-500 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841344Ultraclone Ecl-01-300 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841343Ultraclone Ecl-01-100 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841342Ultraclone Ecl-01-400 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841341Ultraclone Ecl-01-1000 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841340Ultraclone Ecl-01-900 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841339Ultra Clone Ecl-01-700 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841338Ultraclone Ecl-01-600 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841337Ultraclone Ecl-01-800 Cell LineEarl-Clay Laboratories, Inc.KIRClass I
K841196Hy-Bond Zinc Oxide Eugenol Temp.Shofu Dental Corp.EMAClass II
K841118Prolactin Riabead Prolactin RadioimmAbbott MedicalCFTClass I
K841004Surgical Curette, VariousPremier Dental Products CoHCYClass I
K840954Dynamic Condylar Screw or D.c.s.Synthes (USA) Products LLCHRSClass II
K840941Tdx AcetaminophenAbbott MedicalLDPClass II
K840867Alpha-1-Antitrypsin, Fitc, AntigenIntl. Diagnostic TechnologyDEIClass II
K840751Opaque Coating & Surface StainDentsply Intl.EBDClass II
K840623Obstetrical Ultrasound ComputerR & S SystemsHEMClass II
K840333Legionella Bmpa Selective SuppleOxoid U.S.A., Inc.JSKClass I
K840332Campylobacter Agar BaseOxoid U.S.A., Inc.JSJClass I
K840331Legionella Mwy Selective SupplementOxoid U.S.A., Inc.JSKClass I
K840330Preston Campylobacter Selective SuppOxoid U.S.A., Inc.JSKClass I
K834385Yd Strip Glucose U19Yd Pharmaceutical Corp.JILClass II
K834376Filtrare Tm Allvent TmAlltek, Inc.FPBClass II
K834218Diffu-Gen Apolipoprotein a-I Radial -Tago, Inc.MSJClass I
K841698Heat PackMaddak, Inc.IMAClass I
K841695CrawlerMaddak, Inc.KNLClass I
K841598Medium Freq. Electrical Muscle StimulaChattanooga Group, Inc.
K841579Multiplex I, Interferential CurrentHouwers Enterprises, Ltd.IPFClass II
K840891In-the-Ear Hearing Aid Rx10 & 20Audio-Aid, Inc.ESDClass I
K832283Medpar Surgical ImplantsPorex MedicalFWPClass II
K841915Phamas Allergy Mgmt. SystemPharmacia, Inc.
K841725Oslo ArmchairMondial, Inc.INMClass I
K841697Hydro-Thero PadMaddak, Inc.IRTClass II
K841693Standing FrameMaddak, Inc.
K841692Prone StanderMaddak, Inc.
K841691Split Seat Positioning ChairMaddak, Inc.INNClass I
K841674Continuous Passive MotionChattanooga Group, Inc.BXBClass I
K841594Mobilizatioin TableChattanooga Group, Inc.INQClass I
K841528Convaid - Speech AidConvaid, Ltd.ILQClass II
K841485Urological Kit W/sterile, Water-FillMEDLINE INDUSTRIES, LP - NorthfieldKODClass II
K841447Intelect 210 Portable UltrasoundChattanooga Group, Inc.IMIClass II
K841446Intelect 200 Therapeutic UltrasoundChattanooga Group, Inc.IMIClass II
K841445Intelect 205 Portable Ultrasound UnitChattanooga Group, Inc.IMIClass II
K841387Weston Rectal SnareImm Enterprises, Ltd.KOAClass I
K841386Kollmann Urethral DilatorImm Enterprises, Ltd.KOEClass II
K841332Civco/super ScanCIVCO Medical Instruments Co., Inc.IYOClass II