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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 2379 of 3531
510(k) clearances, page 2379 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K902977K3 Computer SystemsDonald L. King M.D.DPTClass II
K921738Sono-Vu Us(tm), ModificationE-Z-EM, IncHIOClass I
K921233Bard 4-Wire Ureteroscopic StoneC.R. Bard IncFFLClass II
K921193Lomefloxacin, 10 Mcg, Sensi DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K921008Vector SeriesSopha Medical Systems, Inc.KPSClass II
K920950Philips EasyvisionPhilips North America LLCLLZClass II
K920911Qcc Custom Canal and Qe1 All IteQualitech Electronics, Inc.ESDClass I
K920776Cardiac Triad Nuclear Imaging SystemTrionix Research Laboratory, Inc.KPSClass II
K920742Hydrajust IV Urological TableMallinckrodt Group, Inc.IXRClass II
K920730X-Ray High Voltage Generator Ed 125LShimadzu Medical SystemsIZOClass I
K920729Bucky Table Bk-12Shimadzu Medical SystemsIXQClass II
K920724High Speed Rotation Starter Sa-50Shimadzu Medical SystemsITYClass I
K920723High Speed Rotation Starter Sa-40Shimadzu Medical SystemsITYClass I
K920715Kodak X-Omat Fixer ManagerEastman Kodak CompanyIXWClass II
K920705Polytron Digital Imaging SystemSiemens Medical Solutions USA, Inc.IZIClass II
K920624Ecat Exact Hr Model 961Siemens Medical Solutions USA, Inc.KPSClass II
K920376Corometrics Model 150 Fetal MonitorGE Medical Systems Information Technologies, Inc.HGMClass II
K915153Escort-Link Arrhythmia Option 23LMedical Data ElectronicsDSIClass II
K913365Accuscope(tm) & Accuscope Ii(tm)Vineland Medical Products, Inc.HEXClass II
K921026Pressure GaugeHobbs Medical, Inc.KNTClass II
K920858Il Test MethadoneInstrumentation Laboratory Co.DJRClass II
K920417Il Test Barbiturate, 35289Instrumentation Laboratory Co.DISClass II
K915751Ureteromat 4400F.M. Wiest USA, Inc.EZNClass II
K913803Intraluminal Artery StripperOmni-Tract Surgical, Div. Minn. Scientific, Inc.DWXClass II
K912093Disposable Aspiration Irrigation SystemApplied Urology, Inc.HETClass II
K911386SleepmasterBiomedical Monitoring Systems, Inc.BZQClass II
K921726Hayek Oscillator, ModificationRespironics, Inc.CBKClass II
K921166Augustine Guide KitAugustine Medical, Inc.CCWClass I
K920468Augustine StyletAugustine Medical, Inc.BSRClass I
K920341Laceration TraysMedikmark, Inc.KKXClass II
K920340Suture Removal KitMedikmark, Inc.KKXClass II
K920339Dressing Change TrayMedikmark, Inc.FRGClass II
K920322OptiearNankivell Industries, Inc.ERAClass I
K920249Bact/alert Pedi-BactbioMerieux, Inc.MDBClass I
K914999Btm-100 Powered Muscle Stimulator (Proposed)Bt Medical Co., Inc.IPFClass II
K914936Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc.LFKClass II
K912070Siemens Radiotom 904 & 904E Electrosurgery UnitSiemens Medical ElectronicsGEIClass II
K905745Ametec Masy Modular Angioscope SystemAmerican Medical Technology, Inc.LYKClass II
K921133Bactec Plus Aerobic/f and Anaerobic/f MediaBD Becton Dickinson Vacutainer Systems PreanalyticMDBClass I
K920817Modification Prospect Giardia Rapid AssayAlexon, Inc.MHIClass II
K920717Needlegard IIIngenious Technologies Corp.FMIClass II
K920331Right Atrial Catheter KitsAkcess Medical Products, Inc.DQYClass II
K920269Ez Gauze SpongeCal West Trading Co.NABClass I
K920257Niacin Control DisksRemel IncJTOClass I
K920174Easy Touch Latex Eam GlovesSimpex, Inc.LYYClass I
K915796Bactec 9240 SystemBD Becton Dickinson Vacutainer Systems PreanalyticMDBClass I
K915690Slt 340 AttcSlt Labinstruments, Inc.JJQClass I
K915689Slt SpectraSlt Labinstruments, Inc.JJQClass I
K915551Ortho Hsv Antigen Elisa TestOrtho Diagnostic Systems, Inc.LGCClass II
K915505Regulator FlowmeterLifeguard Medical Products, Inc.CANClass I