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 2281 of 3531
510(k) clearances, page 2281 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K924587Simultest Cd3/anti-Hla-DrBecton Dickinson Immunocytometry SystemsGKZClass II
K924570Oem Multi-Vac Powered Suction PumpOem Medical Div.GCXClass II
K921389Powderfree Natural Latex GlovesArista Latindo Industrial, Ltd. P.T.LYYClass I
K932951Delfia Testtosterone KitWallac OyCDZClass I
K932729Kodak Ektachem Clinical Chemistry Slides (Phos)Eastman Kodak CompanyCEOClass I
K9323559150A, 1100FDynarad Corp.IZLClass II
K932254Maxima Filtered Hardshell ReservoirMedtronic, Inc.DTBClass III
K931924Marksman Arterial Blood Gas SyringeMartech Medical ProductsJKAClass II
K931887BicarbonateEm Diagnostic Systems, Inc.KHSClass II
K931125Abuscreen Online ControlRoche Diagnostic Systems, Inc.DIFClass I
K931124Abuscreen Online(r) CalibratorsRoche Diagnostic Systems, Inc.DKBClass II
K930422Synelisa Parietal Cell AntibodiesElias U.S.A., Inc.DBJClass II
K930317Rep Spe Hi-Res Template System, Cat 3276/3277/3278Helena Laboratories, Corp.CEFClass I
K930188Ortholoc(r) Advantim(tm) Femoral ComponentDow Corning WrightJWHClass II
K926265Neuro-Care 1000Ems NorthwestIPFClass II
K925758OtoscopeRudolf Riester GmbH & Co. KGERAClass I
K925757OphthalmoscopeRudolf Riester GmbH & Co. KGHLJClass II
K925430Lo-Profile Extensionset W/ .22 Micron FilterDouglas Medical Products, IncFPAClass II
K925058Bard Ambu Pump Spik Tub Set Pacret Provid Pump SetC.R. Bard IncFPAClass II
K924556Patient Examination GloveCenland Industries Sdn BhdLYYClass I
K922714Universal Irrigation & Suction Tubing SetXimed Medical SystemsJOLClass II
K922590Bio-Pen Srk II CalculatorBio-RadLQBClass III
K922321Omni ArthroscopeExpanded Optics, Inc.HRXClass II
K922103Iab AnchorDatascope Corp.KMKClass I
K921050Ultraflo Ratesaver Plus Infusion PumpClinical Systems, Inc.FRNClass II
K920427Percor Stat Dl 9.5 Fr 40Cc Intra-Aortic BalloonDatascope Corp.DSPClass II
K920063Disetronic Dolomat PumpDisetronic Medical SystemsFRWClass I
K933133Spectacle FramesSolitaire Designs, Ltd.HQZClass I
K933046Silver L Module, IteElectone, Inc.LRBClass I
K933045Silver Rechargeable Module, IteElectone, Inc.LRBClass I
K933044Silver Ld Module, IteElectone, Inc.LRBClass I
K933043Silver Ppp Module, IteElectone, Inc.LRBClass I
K933042Silver Compression Module, IteElectone, Inc.ESDClass I
K933041Cold Cd Asp Module, IteElectone, Inc.LRSClass II
K933040Gold Cd Module, IteElectone, Inc.LRBClass I
K933039Gold L Module, IteElectone, Inc.LRBClass I
K933038Gold Af Module, IteElectone, Inc.LRBClass I
K933037Gold K Amp, IteElectone, Inc.LRBClass I
K933036Gold Asp Module, IteElectone, Inc.ESDClass I
K932955Ciba Corning Acs Progesterone ImmunoassayCiba Corning Diagnostics Corp.JLSClass I
K932870Document Chem IV Calibration Verification Test SetCasco StandardsJJXClass I
K931135Altair Eyewear FramesAltair EyewearHQZClass I
K930694Medi-Dyne Angiographic CatheterMedi-Dyne, Inc.DQOClass II
K930673PremiumKCI USA, Inc.FNMClass II
K930597Spectacle FramesVenis di Alessandro VendrameHQZClass I
K930205Electric Wire Driver, Model 2640EMicro Surgical Instruments Corp.HXJClass I
K930190Ortholoc(r) Advantim(tm) Non-Por Coat Femor CompDow Corning WrightJWHClass II
K926237O'brien GoniometerSgarlato Laboratories, Inc.KQWClass I
K925671Disposable Scleral PlugsO.R. Specialties, Inc.LXPClass II
K925506Rusch Safety Clear Uncuffed with Murphy EyeRusch, Inc.BTRClass II