510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 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 2358 of 3531
510(k) clearances, page 2358 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K922755Pulpdent Hard CorePulpdent CorporationEBFClass II
K922700Du Pont Aca Plus Immunoassay System Mb Mckmb Meth.E.I. Dupont de Nemours & Co., Inc.JHYClass II
K922680Du Pont Aca Plus Immunoassay System InstrumentE.I. Dupont de Nemours & Co., Inc.JJEClass I
K922513Comfit Sterile Latex Examination GloveWembley Rubber Products (M) Sdn BhdLYYClass I
K922417Al-Acid Glycoprotein Rid KitThe Binding SiteLKLClass I
K921393Imagica Micro-EndoscopeFiberoptic Medical Products, Inc.EOQClass II
K921328Stc Diagnostics Auto-Lyte Opiate EiaSolarcare Technologies Corp,Inc.DJGClass II
K921140Stc Diagnostics Auto0lyte Cocaine Metabolite EiaSolarcare Technologies Corp,Inc.JXOClass II
K920714Vista Hpq SystemPhilips North America LLCLNHClass II
K920401Immunowell Cardiolipin Antibody (Igm) TestGeneral Biometrics, Inc.MIDClass II
K920400Immunowell Cardiolipin Antibody (Igg) TestGeneral Biometrics, Inc.MIDClass II
K920212Mycoplasma Pneumoniae Antibody Eia Test SystemShared Systems, Inc.LJZClass I
K914959Magic Lite Sq Specific Ige Immunoassay SystemCiba Corning Diagnostics Corp.DHBClass II
K922542Grasping ForcepsSurgitekFGOClass II
K922273Array(r) 360Beckman Instruments, Inc.JQXClass I
K922003Antimicrobial Suscetibility Test PanelAlamar Biosciences Laboratory, Inc.JWYClass II
K920884Guidewires, Various TypesAcme-Monaco Corp.DQXClass II
K923608Olympus Direct Bilirubin ReagentOlympus Corp.CIGClass II
K923564Olympus Inorganic Phosphorus ReagentOlympus Corp.CEOClass I
K923411Olympus Magnesium ReagentOlympus Corp.JGJClass I
K923380Siemens Model Triton 3004 BSiemens Hearing Instruments, Inc.ESDClass I
K923379Siemens Model Infiniti 1001 BSiemens Hearing Instruments, Inc.ESDClass I
K922964King Diagnostic Triglycerides ReagentKing Diagnostics, Inc.CDTClass I
K922770Unistat Bilirubinometer Models 10310 and 10311Leica, Inc.MQMClass I
K922391Endoscopic Carpal Tunnel InstrumentsInstratek, Inc.HRXClass II
K922355Polly's Vitreous Scissors J-225-SO.R. Specialties, Inc.HQEClass II
K922053Rep Spe Plus (Ponceau S) SystemHelena Laboratories, Corp.CEFClass I
K921825Quick-Check II Reagent StripDiagnostic Solutions, Inc.CGAClass II
K921612Intertron 4500, Intertron 5000, Masterstim I-2Medstar, Inc.LIHClass II
K921223Acs Freeze-Dried Aptt ReagentAnalytical Control SystemsGFOClass II
K920675Duoderm Sustained Compression BandageConvatec, A Division of E.R. Squibb & SonsKGXClass I
K920405Sterile Surgeon's GownAmsco Sterile Recoveries, Inc.FYAClass II
K920404Surgeon's GownAmsco Sterile Recoveries, Inc.FYCClass II
K920295Medilog Excel ECG Analysis System (Modified)Oxford Medilog, Inc.DQKClass II
K915512Duracon Total Knee System Tibial ComponentsPfizer Hospital Products Group, Inc.JWHClass II
K922466Comfeel Wound Dressing SdMEDLINE INDUSTRIES, LP - NorthfieldKMFClass I
K922461Comfeel Wound Dressing OrdMEDLINE INDUSTRIES, LP - NorthfieldKMFClass I
K922373Multispect(tm) 2 Dual Detector Camera SystemSiemens Gammasonics, Inc.KPSClass II
K922372Multispect(tm) 3 Triple Detector Camera SystemSiemens Gammasonics, Inc.KPSClass II
K922181Coulter Mh009Coulter Electronics, Inc.GKZClass II
K921921Catheter CholangiographyLaparomed Corp.GEIClass II
K920820Modification ColumnmateHelena Laboratories, Corp.LCPClass II
K920518E.r. Suture Tray, Sterile, DisposableTrinity Laboratories, Inc.KKXClass II
K915530Nova Gauze(r) Disposable Nonwoven Sponges, SterileAmerican Threshold Industries, Inc.HAXClass II
K915347Scimed Viper CatheterScimedLITClass II
K914489New Extrusion Vendor for Polyurethane TubingTelectronics Pacing Systems, Inc.DTBClass III
K923398Cpi Model 2215Seamed Corp.DTEClass II
K923013Acoustic Appraise Cd-3QualitoneEWOClass II
K922405O.r.c. AdapterO.R. Concepts, Inc.GCJClass II
K922349Dowd(tm) IIBoston Scientific CorporationKOEClass II