510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 2386 of 3531
510(k) clearances, page 2386 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K914020Modified Asahi Pan-Series HemofiltersAsahi Kasei Medical MT Corp. Oita WorksKDIClass II
K913873System 3000 Electronic InsufflatorCabot Medical Corp.HIFClass II
K911911Medical Designs, Inc. Bio-Therapy SystemMedical Design & Manufacturing Corp.HCCClass II
K921023Beltone Opra Clear Voice-K Hearing AidBeltone Electronics Corp.ESDClass I
K920897Rionet Hearing Aid - Hb 52DuAuthorized Hearing Systems, Inc.ESDClass I
K920888Microlite Microtiter Plate Luminometer Ml2200Dynatech Laboratories, Inc.KHOClass I
K920887Gdc-3338, Dental Solder AlloyDeringer-Ney, Inc.EJSClass II
K920559Abbott Vertex AnalyzerAbbott MedicalJJJClass I
K920365Tooth Bonding AgentVoco GmbHEBFClass II
K920317S-Rom Lf Femoral HeadJoint Medical Products Corp.JDIClass II
K920018Accuscreen AssayJk ResearchDKZClass II
K915808Aqueous Paracentesis PipetVisitec Co.KYGClass I
K915721Model Ar-6300 Infusion PumpArthrex GmbHHRXClass II
K915693Proximate Absorbable StaplesEthicon, IncGDWClass II
K915543New Opaque PorcelainDentsply Intl.EIHClass II
K915099Endopath Endos Linear Cut W/saf Lock-Out/reload UnEthicon, IncGCJClass II
K915057Cann-HoldO.R. Concepts, Inc.KGXClass I
K915053Beckman Antistreptolysin O, ModificationBeckman Instruments, Inc.GTQClass I
K9148251-125 EndoseedEndo Technic Corp.KXKClass II
K914597Surgical Microporous Tape (Microcel)Industrias Tuk, S.A. de C.V.KGXClass I
K914596Surgical Cloth Tape (Healrite)Industrias Tuk, S.A. de C.V.KGXClass I
K914513Palavit GKulzer GmbHEGDClass I
K914108Rg27-Series Resectoscope and AccessoriesCooperSurgical, Inc.HIHClass II
K912138Homevue Monitoring Sys.model Td 2000Homevue Health Systems, Inc.HGMClass II
K910929Ohmeda Modulus Cd Anesthesia System with C.v.GE HealthcareDSIClass II
K920957Phencyclidine Eia Assay, ModificationDiagnostic Reagents, Inc.LCMUnclassified
K920935Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc.LCMUnclassified
K920900Polamedco Tracheal and Nasotracheal TubesPolamedco, Inc.BTRClass II
K920749Thc Urine CalibratorsDiagnostic Reagents, Inc.DLJClass II
K920691The Lewis Tube HolderR. Lewis, Inc.CBHClass I
K920477Drug of Abuse Urine ControlDiagnostic Reagents, Inc.DIFClass I
K920442Immuchem Tsh-Mw ElisaIcn Biomedicals, Inc.JLWClass II
K920345Prolactin Enzyme Immunoassay Test Kit (Modified)Medix Biotech, Inc.CFTClass I
K920274Directigen Neisseria Meningitidis TestBD Becton Dickinson Vacutainer Systems PreanalyticGTIClass II
K920251Usci Hemaquet Xt IntroducerC.R. Bard IncDYBClass II
K920150Encore Scl-70Trinity Biotech USALKJClass II
K920034Duracon Modular Femoral Component and Femoral SpacPfizer Hospital Products Group, Inc.JWHClass II
K920030Sureseal Endoscopic ValveApplied Urology, Inc.ODCClass II
K915854Endoscopic TransluminatorO.R. Concepts, Inc.GCJClass II
K915838Opus Ferritin Test SystemPb Diagnostic Systems, Inc.DGEClass II
K915803Dma Ld Kinetic ProcedureData Medical Associates, Inc.CFJClass II
K915763Modified Disposable Fetal VacuumColumbia Medical & Surgical, Inc.HDBClass II
K915670Microaire Model 2600MicroaireGEFClass I
K915661Techna Sun LensTechna Intl.HQYClass I
K915605Sunglasses/reading GlassesRoyal Shine Enterprises, Ltd.HQYClass I
K915392Accent Dg Balloon Urteral Dilator Set, 10CmCook IncorporatedEZNClass II
K915113EncoreKulzer GmbHJJQClass I
K914958Riatrac PlusBecton Dickinson Advanced DiagnosticsJJYClass I
K914475IV Start KitCypress Medical Products LLCLRSClass II
K914216Frenta II+ Enteral Feeding PumpFresenius PharmaLZHClass II