510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3384 of 3526
510(k) clearances, page 3384 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K792239Ela Medical Anatec Holter ScannerEla Medical, Inc.
K792110Conphar Face Mask-SterileConphar, Inc.FXXClass II
K792106Conphar o.r. Head Cover-SterileConphar, Inc.FYIClass I
K792073Model 1979 Blood Pressurometer R CharterDel Mar AvionicsDRSClass II
K792072Model 685/686 Dynamic Electrocardi0-Del Mar AvionicsDPSClass II
K792055Fisher Diagnostics Hematology ControlsFisher Scientific Company L.L.C.JPKClass II
K792048Lancer Coagent Aptt KitSherwood Medical Co.GGWClass II
K792031Lancer Coagent Pt KitSherwood Medical Co.GJSClass II
K792019Phadecode Xa Inhibitor AssayPharmaseal Div., Baxter Healthcare Corp.JBQClass II
K792004Hewson Ligament ButtonRichard'S Medical Equip., Inc.KGSClass I
K791971Monoject Sickle Cell KitSherwood Medical Co.GHMClass II
K791969Dynacor Sterile Closed Sys. Drainage BagMEDLINE INDUSTRIES, LP - NorthfieldKNXClass II
K791962Worthington Triglycerides Reagent SetWorthington Diagnostic SystemsJGYClass I
K791916Pelican Bay Kel-Cor Cephalometric Sys.Pelican Bay Kel-CorIXYClass I
K791892Tape-a-TraceInstromedix, Inc.DXMClass II
K791881Rionet Hearing Aid Hb-65TRion Acoustic Instruments, Inc.ESDClass I
K791880Rionet Hearing Aid Hb-64TRion Acoustic Instruments, Inc.ESDClass I
K791878Rionet Hearing Aid Hb-64CRion Acoustic Instruments, Inc.ESDClass I
K791871Neurological Sponges (Patties)Carwild Corp.EFQUnclassified
K791870Disposable Speciality SpongesCarwild Corp.GDIClass I
K791867Royco Model 921 Cell CounterRoyco InstrumentsGKLClass II
K791857Hollow Fiber Dializer Model Triex-3Extracorporeal Medical Specialities, Inc.
K791812Spectrum Emergency & Trauma Table SystemSpectrum X-Ray Corp.IXRClass II
K791768Cordis Permanent Pervenous Cardiac LeadsCordis US Corp.DTBClass III
K791765Masterson* Endometrial Biopsy KitCerenovus, Inc.HHKClass II
K791763(Micro-Keratron, Micro Duct Trephine)Intl. Ophthalmic Industries Corp.HRGClass I
K791739Rionet Hearing Aid Model Ha-55Rion Acoustic Instruments, Inc.ESDClass I
K791720Ar/mde Infusor Model 60/2 Infusion PumpAlza Corp.FRNClass II
K791674Bladder Retention Catheterization TrayLatex Ind., Inc.KODClass II
K791422Minispirometer Sp-1Renesco International, Inc.BZGClass II
K791202Ria Kit for TrypsinCis Radiopharmaceuticals, Inc.JNOClass I
K790808Protein Assay KitSpecialty Medical Industries, Inc.CEKClass II
K792085C-Era-100 Computerized Electric ResponMicro-Shev, Ltd.GWJClass II
K792069Tracheostomy Care KitNational Patent Development Corp.BTOClass II
K792064Delta Rolling Self-Licking WalkerStaricat, Inc.ITJClass I
K792047Circuit, Breathing (W/ Connector, Adapt,Airlife, Inc.BZOClass I
K792046Uric Acid StandardGilford DiagnosticsJISClass II
K792045Biovation NephelometerBiovation, Inc.JQXClass I
K792043Pap-Check Ria KitSerono Laboratories, Inc.JFHClass II
K792041Dhea-Sulfate Test SetWien Laboratories, Inc.JKCClass I
K792039William Harvey H-1500 Blood OxygenatorC.R. Bard IncDTZClass II
K792036Cortisol Radioimmunoassay SystemRadioimmunoassay, Inc.CGRClass II
K792030Two-Piece I.p.p.b. Manifold-with RightAirlife, Inc.BZOClass I
K792027Pregtell ICentral Biological Co.JHJClass II
K792025Lyophilized Hdl Cholesterol ControlsHelena Laboratories, Corp.JJYClass I
K792024LipotrolHelena Laboratories, Corp.JJYClass I
K792023Eskachem, Ck-Mb ReagentSmithkline Diagnostics, Inc.JHSClass II
K792017Volu-Sol Stat StainVolu Sol Medical IndustriesIAFClass I
K792000Luteinizing Hormone (Lh) RiaCis Radiopharmaceuticals, Inc.CEPClass I
K791999(125I) Testosterone KitRadioassay Systems Laboratories, Inc.CDZClass I