510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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
45,969 of the 176,366 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
20262,569
176,366 records, page 3070 of 3528
510(k) clearances, page 3070 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K842085Automated Eia Microplate Reader El310Bio-Tek Instruments, Inc.JJQClass I
K841992Modification to Acs Coronary GuidingAdvanced Cardiovascular Systems, Inc.DAOClass II
K841812Holder for Bos-10, 10S 5SAmerican BentleyKRIClass I
K841677Sterile Blood LancetsAbco Dealers, Inc.FMKClass II
K841538Impact Model 308ZOLL Medical CorporationJCXClass II
K841504Quick-Count Plus 2Seragen Diagnostics, Inc.GKLClass II
K841493Model 1000 Apc-Angioplasty PressureE.A. Fischione Instrument Mfg.DXTClass II
K841482Pressure Catheter Placement Set 50010Dlp, Inc.DWFClass II
K841455Reuseable Non-Conductive Fixed YDryden Corp.CAIClass I
K841402Temperature Control & MonitorSams, Inc.DWCClass II
K841317Deseret Heparin Coated Flow DirectedParke-Davis Co.DYGClass II
K841296Tube TenderThe Anspach Effort, Inc.KRIClass I
K841251Deseret Heparin Coated Flow CathParke-Davis Co.DYGClass II
K841085Scanlan Colormark Skin MarkerScanlan Intl., Inc.FZZClass I
K840900Porta Pak 90Medical Research Laboratories, Inc.LDDClass II
K840761Silvertorque Visceral CatheterSurgimed Corp.DQYClass II
K840669Suction Device-Pharyneal DeviceLipsky-Dale Medical ProductsJOLClass II
K834547Angioscopy CatheterAmerican Edwards LaboratoriesLYKClass II
K834024HeparinometerWestern Laboratories Corp.KFFClass II
K833873Cardiosearch Right Atrial Cath-Cardio Search, Inc.DQYClass II
K842120Zero-GSteridyne Corp.KICClass I
K841703Tdx Rea LdhAbbott MedicalCFJClass II
K841664Enzymatic CO2 Diagnostic ChemicalDiagnostic Chemicals, Ltd. (USA)KHSClass II
K841008Biopsy Punch, VariousPremier Dental Products CoGEEClass I
K842125Allercoat Allergen DiscsKallestad Laboratories, Inc.DGCClass II
K842101Coba AgarNeogen Culture MediaJSIClass I
K842100Macconkey Agar, PlusNeogen Culture MediaJSIClass I
K842097Rim Spot IndoleAustin Biological LaboratoriesJSFClass I
K842072L-Alanine-4-NitroanilideIrvine Diagnostic ServicesJSFClass I
K842057Maclean-Fogg, Dispos-Inocula-LoopsPolymer Technology Corp.LIBClass I
K842028Cm-Trisacryl M Deae-Trisacryl MLkb Instruments, Inc.KEAClass I
K841908Spectacle FramesCosmas Optical USA, Ltd.HQZClass I
K841892Raichem Bilirubin Reagent Total/directReagents Applications, Inc.CIGClass II
K841856Amer. Med. Optics Argon/krypton LaserAmerican Medical OpticsHQFClass II
K841829Phadebas Rast Phadezym Rast AllergenPharmacia, Inc.DGCClass II
K841824Pharmacia Ige RiaPharmacia, Inc.DGCClass II
K841806Wi-38Viromed Laboratories, Inc.KIRClass I
K841793Cooper Lasersonics Nd:yag Laser 8000Cooper Lasersonics, Inc.
K841784Flexiflo-III Portable Enteral NutriAbbott MedicalFRNClass II
K841753Macconkey AgarThe Montana Deaconess Medical CenterJSIClass I
K841752Xylose-Lysine Desoxycholate AgarThe Montana Deaconess Medical CenterJSIClass I
K841747Mannitol Salt AgarThe Montana Deaconess Medical CenterJSIClass I
K841727Urological Catheter & AccessoriesResearch Medical, Inc.KODClass II
K841726Demand C02Cooper Biomedical, Inc.KHSClass II
K841685EEG ElectrodesBio-Scan, Inc.GXYClass II
K841684Bio/scan Biolog Cassette RecorderBio-Scan, Inc.GWQClass II
K841683Q.p. Preamplifier SysBio-Scan, Inc.GWQClass II
K841662Maximum Recovery DiluentOxoid U.S.A., Inc.JSGClass I
K841659Drigalski Litmus Lactose AgarOxoid U.S.A., Inc.JSFClass I
K841642Mast Luminescent Allergy SysMast ImmunosystemsDGCClass II