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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
45,902 of the 176,299 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
20262,502
176,299 records, page 3487 of 3526
510(k) clearances, page 3487 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770779Phenytoin Ria KitAmersham Corp.DLPClass II
K770752Reagent, Chloride, CoulterCoulter Electronics, Inc.CHJClass II
K770702In Vitro Ferritin Ria TestClinical Assays, Inc.DBFClass II
K770658Exerciser, Leg, Lower ExtremityRobert R. MooreIONClass I
K770613Ldh Ultrazyme PlusHarleco DiagnosticsCFJClass II
K770577Deter. of Phosphohexose IsomeraseSigma Chemical Co.KLJClass I
K770550Atypia Profile MonitorGeometric Data, Div. Smithkline Corp.GKZClass II
K770412ProphalacticsJamar Health Products, Inc.HISClass II
K770605Tubes, Hydrolysis, CalibratedOrganon LLC
K770446Sponges, LaparotomyWalpak Co.EFQUnclassified
K770362Tape, Dermicel, ClothJohnson & Johnson Professionals, Inc.KGXClass I
K771021Auto-ClipAxiom Medical, Inc.DSSClass II
K771019Lung-Mechanics MonitorResearch Development Corp.BZQClass II
K771017Citadel CPAP Accessory KitSherwood Medical IndustriesCAIClass I
K771014Ts-100 Test SystemDelta Medical IndustriesKRCClass II
K770988Foam ECG Electrode, 2060 and 2061Cardio-Dynamics Laboratories, Inc.DRXClass II
K770987Nerve Stimulator, Molel No. Fb-800Output, Inc.GZIClass II
K770977Cardiovascular Spring GuidesLake Region Mfg., Inc.DQXClass II
K770960Hearing Aid, Series RMaico Hearing Instruments, Inc.ESDClass I
K770959Bougie, Filiform, JacksonV. Mueller O.V. Baxter Healthcare Corp.KBIClass I
K770958Bandage, Unipress, ClarionSherwood Medical IndustriesFQMClass I
K770957Pediatric Blood Culture BottlesGibco Laboratories Life Technologies, Inc.JTWClass I
K770915Clasp Ria Kit, HtshE. R. Squibb & Sons, Inc.JLWClass II
K770892Tsh RadioimmunoassayKallestad Laboratories, Inc.JLWClass II
K770867Dialyzer, Fiber, HollowCobe Laboratories, Inc.FJIClass II
K770865Monitor, PacemakerAdcor Electronics, Inc.DTCClass II
K770863Flu Ven 0160Venospital, Inc.FPAClass II
K770858Dialyzer, Ultradiffuser, DisposableGambro, Inc.FJGClass II
K770843IV Pump Filterset, UniversalAbbott MedicalFPBClass II
K770703Filter Unit, Single UseEMD Millipore CorporationFPBClass II
K770699Needle Set, a-V FistulaMedical Disposables Intl., Inc.FIEClass II
K770687Measlesvirus Floure. Conjugated AntiseruMicrobiological Assoc.GREClass I
K770648Quantimune T-3 RiaBio-RadCDPClass II
K770601Analyzer, Sodium/potassium Nova LNova Biomedical CorporationJGSClass II
K770410Bandage Compress 2, 3, 4Johnson & Johnson Professionals, Inc.NABClass I
K770975Anti-Convulsant Drug ControlLederle LaboratoriesDICClass II
K770968Monitor, Patient, Model Pm-I0nCavitron Corp.CCKClass II
K770925Improved Thayer-Martin MediumMicro-Tech Diagnostic, Inc.JTYClass II
K770874Improved Thayer Martin (Plate)Granite Diagnostics, Inc.JTYClass II
K770848Daily-WeightSr Instruments IncFRIClass I
K770847Porta-ScaleSr Instruments IncFRIClass I
K770840Pre-Reduced Anaerobic MediaGibco Laboratories Life Technologies, Inc.JSLClass I
K770839Aquamatic K-77Gorman Rupp IndustriesDWJClass II
K770833Fluoretec-MPfizer IncGMYClass I
K770763Burette Set, 2C0132Travenol Laboratories, S.A.FPAClass II
K770708Tygon Pac-StopcocksNorton Performance Plastics Corp.FMGClass II
K770570Calcium/magnesium AnalyzerBeckman Instruments, Inc.JFNClass II
K770495Quanti. Colori. Det. of Serum IronSigma Chemical Co.
K770483Cholesterol ReagentSmithkline Diagnostics, Inc.CHHClass I
K770533Band-Aid Brand Adhes. Band.-Sheer StripsJohnson & Johnson Professionals, Inc.FPXClass I