510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3035 of 3529
510(k) clearances, page 3035 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K842224Bns 40Myo-Tronics Research, Inc.NUWClass II
K842223J4 Myo-MonitorMyo-Tronics Research, Inc.NUWClass II
K841730Bailey Lens ShooterIntermedics Intraocular, Inc.KYBClass I
K841235Medo Medomer Mbf-100 IIMedo U.S.A., Inc.JOWClass II
K844144Scd Sterile Connection DeviceE.I. Dupont de Nemours & Co., Inc.FKXClass II
K843980Personal Amplifier SilencerElectone, Inc.ESDClass I
K843869TranquilityPrinciple Business Ent.EYQClass I
K843644Storz Aspiration Machine Sam 5000Storz Instrument Co.BTAClass II
K843636Foam Care One Step PrepBallard Medical ProductsGECClass I
K843623Unilyte aMedical Enterprises, Ltd.FKQClass II
K843531Asn Monitor Single Needle MonitorbioMerieux, Inc.KOCClass II
K843470Pharma-Plast Connecting Tube Type Suct-Zimmar Consulting, Ltd.BYYClass II
K843190Hap Acetabular CupDepuy, Inc.JDIClass II
K842808Uritrol-MThe Washington Group, Inc.KNTClass II
K842123Personal Cl Single-Channel ElectrocarParexel Intl. Corp.DSIClass II
K844149Ambu Ruben Circle Anesthesia SystemAmbu, Inc.CAIClass I
K843993Anaeslock Three Vaporizer Interlock Hva003Southmedic Inc.CADClass II
K843909Titanium Hip 1019Depuy, Inc.JDIClass II
K843835Ohmeda PEEP Valve for Gms AbsorberGE HealthcareBYEClass II
K843450Argyle Silicone Central Venous Cath-Sherwood Medical Co.LJSClass II
K843331Intermedics/graseby Dynamics Ms 36Intermedics, Inc.FRNClass II
K844225Link Acetabular MeshWaldemar Link GmbH & Co. KGFTMClass II
K843951SirognathographSiemens Medical Solutions USA, Inc.NFSClass I
K843780Vent-a-CastOrthopedic Technology, Inc.LGFClass I
K843705Mandibulator Jaw PositionerA Company, Inc.DYJClass I
K843433Kanievski Sensory Aid or DeviceSpectro Industries, Inc.LRAUnclassified
K843369Agglutination Test for Total IgeScientific ResearchDGCClass II
K843203Cryo Massage CupCryo Therapy
K844156Urea Nitrogen Reagent SetLivonia Diagnostics, Inc.CDWClass II
K844086Pos Combo PanelAmerican Micro ScanJTOClass I
K844058Code-a-Wall Series 1-250 Inoculum TrayPlastic Injectors, Inc.
K844045Advanced Cardiovascular Systems AngiojectAdvanced Cardiovascular Systems, Inc.DXTClass II
K843892Micro Hematocrit Capillary TubesAbco Dealers, Inc.GIOClass I
K843804Tandem - EprlHybritech, Inc.CFTClass I
K843558Deltanode, Mega Delta, Delta Link-Computer Design & Applications, Inc.IYXClass I
K843285Tri-Med 610 Capnostat Gas AnalyzerTri-Med, Inc.CCKClass II
K843164Coulter Counter Model ZmCoulter Electronics, Inc.GKLClass II
K843118Cannula IntroducerCardiovascular Research, Inc.DYBClass II
K834212N-ChannelPhilips North America LLCLOS
K844182Inorganic Phosphorus Reagent SetLivonia Diagnostics, Inc.CEOClass I
K844169VolumaticGlaxo, Inc.KCDClass I
K844047Fisher Diagnostics Sera Chem Smac CalibratorsFisher DiagnosticsJITClass II
K844032Triglyceride ReagentSigma Diagnostics, Inc.CDTClass I
K844000Rionet Hearing Aid Hb-73Rion Acoustic Instruments, Inc.ESDClass I
K843791Behind-the-Ear 123 VthDanavox, Inc.ESDClass I
K843742Unitek Convertible Cap Remover ToolUnitek Corp.JEXClass I
K843722Orthodontic WireArthur L. WoolDZCClass I
K842832A.s.p.c./clearsoundAsl, Inc.ESDClass I
K842669Titan Gel ISO Dot Ldh KitHelena Laboratories, Corp.CFEClass II
K842381Sls 3500 LED Visual StimulatorNihon Kohden America IncGWEClass II