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 3247 of 3528
510(k) clearances, page 3247 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K820214SucroseDms LaboratoriesJSEClass I
K820208Zyme aDms Laboratories
K820207Nit 2Dms LaboratoriesJTOClass I
K820206Nit 1Dms LaboratoriesJTOClass I
K820205Vp 2Dms LaboratoriesJTOClass I
K820204Vp IDms LaboratoriesJTOClass I
K820203Fluid Administrative Set, AfiLinton Biomed Corp.FPAClass II
K820188Phenobarbital AssaySyva Co.LETClass II
K820180Calculi Filter CupOmnimedicalFMHClass I
K820177Coagulase PlasmaQuadroma, Inc.JTLClass I
K820176Vygon Enternal Nutrition TubesExco, Inc.KNTClass II
K820170Med-Care Emergency ShearsMedcare ProductsFZTClass I
K820169Male Luer Connector & Hinged CapExtracorporeal Medical Specialities, Inc.FJKClass II
K820158Olsen #770 Disposable HolsterOlsen Electro-Surgical Instruments, Inc.KDCClass I
K820154Tdx DigoxinAbbott MedicalLCSClass II
K820149Pyr BrothCarr-Scarborough Microbiologicals, Inc.JSFClass I
K820147Steri-ShureGeneral Health Systems, Inc.JOJClass II
K820142Tubular StockinetteStan-Pak Ent.FQMClass I
K820141Bias StockinetteStan-Pak Ent.FQMClass I
K820139Sof-Rol Cast PaddingStan-Pak Ent.NABClass I
K820137Immu-CountKemble Instruments, Inc.JJJClass I
K820134Vigilon Primary Wound Dressing, SterileC.R. Bard IncKMFClass I
K820130Advance System Emit-Amd Tobramycin AssaySyva Co.LCRClass II
K820115Emmett IUD Thread RetreiverProto-Med, Inc.HHFClass I
K820105Combine Pad or AbdStan-Pak Ent.NABClass I
K820079Airmed Pneumatic Equip. Filtra/controlJames L. Geraci & Associates, Inc.BTIClass II
K820056Telfa StripsStan-Pak Ent.NABClass I
K820030Howmedica Kinematic Total Condylar KneeHowmedica Corp.HRYClass II
K820026Vitre ConMedical Instrument Development Laboratories, Inc.HQEClass II
K813607Ackrad N-Do Vage TubeAckrad LaboratoriesFQHClass II
K813544Irex 2D/doppler Phase Array Imaging Sys.Irex Corp.IYNClass II
K813274Blood Pool & Subvetinal Fluid AspiratorOptical Micro Systems, Inc.HQEClass II
K813258Ultimate-AireHawkins Intl.FRFClass II
K813190Soft Plate CushionLeonard Russo Co.EHSClass II
K812903Hutt Swivel Walker & Hutt Standing FrameBarnett Medical
K812857Charles Micro ProbeMid Laboratories, Inc.HQEClass II
K820236Water Floatation PadGottfried Medical, Inc.KICClass I
K820226Universall Drill GuideOrtho Pared Instruments, Inc.HTWClass I
K820225Meniscus ExtractorOrtho Pared Instruments, Inc.HRXClass II
K820118Electrolyte Analyzer AccessoryBoehringer Mannheim Corp.JJEClass I
K820098Roller GauzeStan-Pak Ent.NABClass I
K820097Sheet Wadding Cast PaddingStan-Pak Ent.NABClass I
K820096Vag PackingStan-Pak Ent.NABClass I
K820095Tonsil SpongesStan-Pak Ent.NABClass I
K820087Codman * Reusable PerforatorCerenovus, Inc.HBFClass II
K820078Drape, SurgicalJames L. Geraci & Associates, Inc.KKXClass II
K820070Msi Sternum Aspiration NeedleCreative Research and Mfg., Inc.GAAClass I
K820066Electroencephalographs EEG-5208,5210Nihon Kohden America IncGWQClass II
K820053Kerlix FluffsStan-Pak Ent.NABClass I
K820052Safety PinsStan-Pak Ent.LDQ