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 3140 of 3528
510(k) clearances, page 3140 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K832114Coatest Factor XKabivitrum, Inc.GGPClass II
K832063Robin Cordless HandpieceKaycor Intl., Ltd.EKXClass I
K832054Fiax Crp Test KitIntl. Diagnostic TechnologyDCKClass II
K831834Raichem Acid Phasphatase ReagentReagents Applications, Inc.CKBClass II
K831779Collins Eagle IIWarren E. Collins, Inc.BZCClass II
K831501Tactil EarEar Three SystemsLRAUnclassified
K831373P.c.a. Hip SystemHowmedica Corp.JDIClass II
K831029Hemoperfusion System Tp-400Extracorporeal Medical Specialities, Inc.FLDClass II
K830763Fr Root Canal FillerShizai Corp.KIFClass II
K831661Disposable ScissorsMedcare ProductsKDCClass I
K832398Dynacor Connecting TubingMEDLINE INDUSTRIES, LP - NorthfieldBYYClass II
K832329Sterile IV Set 4 SizesAbco Dealers, Inc.FPAClass II
K832306Bile Aesculin DiscsOxoid U.S.A., Inc.JTOClass I
K832305Sps DiscsOxoid U.S.A., Inc.JTOClass I
K832251Preciset Cholesterol High PerformBoehringer Mannheim Corp.JISClass II
K832210Gamma Photon Gamma CounterMedical & Scientific Designs, Inc.JJJClass I
K832209Kineti Count 24 Gamma CounterMedical & Scientific Designs, Inc.JJJClass I
K832206Spectrophotometer #390Abbott DiagnosticsJJQClass I
K832205Precision Liquid DispenserHamilton CoJQWClass I
K832204Microlab PHamilton CoJQWClass I
K832202Pb 600 Repeating DispenserHamilton CoJQWClass I
K832183Sandare Calcium ProcedureSandare Chemical Co., Inc.CICClass II
K832087Titan Gel Glyco-Heme SystemHelena Laboratories, Corp.LCPClass II
K832059Ionophorelic Sweat Stim. Chloride-Medtronic, Inc.KTBClass II
K831845Per-Q-Cath TrayGesco Intl., Inc.LJSClass II
K831733Temperature Module 242-100Kontron Instruments, Inc.FLLClass II
K831670Ortho*pap-Ia Endogenous Enzyme ImmunoOrtho Diagnostic Systems, Inc.JFHClass II
K831657Alka First Aid KitAlka, Inc.FROUnclassified
K831649Thermomixer S213-Photoanalyzer S263Texas Intl. Laboratories, Inc.JJEClass I
K831636Percutaneous Introducer KitAccu-LineDQYClass II
K831557Intraoperative Autotransfusion SysThoratec Laboratories Corp.CACClass II
K831387Hs-100 Headspace Sampling AccessoryRevvity Health Sciences, Inc.KZQClass I
K831063Button InfuserMarkwell Medical Institute, Inc.FMIClass II
K830797Immobiline System Lkb 1819Lkb Instruments, Inc.JJNClass I
K837776Aor X-Ray Aligment PadZimmer GmbHIXJClass I
K832494ScoliometerMizuho Orthopedic Systems Inc
K832477OculopressorHans Gevder
K832473Gamma Slide Test for PregnancyGamma Biologicals, Inc.JHJClass II
K832464Massage Table Aat-100R & D Systems, Inc.JFBClass II
K832461PolycorePolycore Optical Pte, Ltd.
K832437Medic Lux Diagnostic SetsKeeler Instruments, Inc.HLJClass II
K832331US-1000 Ultrasonic Imaging SystemNidek, Inc.IYOClass II
K832302Mark I Total Knee Sys. ArthroplastyAdvanced Biosearch Assn.MBVClass II
K832277Acuflex Levy Acl Drill Guide SysAcufex Microsurgical, Inc.HRXClass II
K832237Orthopedic Casting Tape MaxcastCutter Laboratories, Inc.ITGClass I
K832201Chrom-PrepHamilton CoKZRClass I
K832200Prp-1 Reversed Phase Columns for HplcHamilton CoDPMClass I
K832199Hc40/hc75 Cation Exchange ResinHamilton CoDNHClass I
K832175Digilab 350 the Krakau PerimeterBio-RadHPTClass I
K832169Total Protein ProcedureSandare Chemical Co., Inc.CEKClass II