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 3057 of 3528
510(k) clearances, page 3057 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841261Computer, Central Processing UnitNem Computer Corp.DXGClass II
K840961Eschweiler Combi-Analyser Mta-500U.S. Science, Inc.CEMClass II
K840903Helena Coloscreen Self-TestHelena Laboratories, Corp.KHEClass II
K834429Peripheral Dilatation Angioplasty-CathAmerican Edwards LaboratoriesLITClass II
K842955Sickle-Heme a/s Heterozygous ControlMichClone Associates, Inc.GHMClass II
K842902Microstat Gamma CounterMicromedic SystemsJJJClass I
K842609R.l. Medical Twin Light SourceTridak Division of Indicon, Inc.FCWClass II
K842406Wescott Type Biopsy NeedlePopper & Sons, Inc.
K842163Ridgematrix 20/40 Mesh, PeriomatrixOrthomatrix, Inc.LYCClass II
K841905Dot-a, Dot-Ar Pxp-E, Pxp-ErSiemens Gammasonics, Inc.JWMClass II
K843114Ampco Procedure Trays / PacksAssociated Medical Products Co.
K842882Ankle MobilizerJoint Mobilizer Systems, Inc.BXBClass I
K842881Knee-Hip MobilizerJoint Mobilizer Systems, Inc.BXBClass I
K842864Vaccess Femoral CannulaVas-Cath of Canada, Ltd.KNZClass II
K842812Mentor 150 Plus Transcutaneous Elec.MentorGZJClass II
K842791Ortho Active Wrist BraceOrtho Active Appliances, Ltd.
K842790Ortho Active Knee BraceOrtho Active Appliances, Ltd.
K842670Biolas Yag 100Advanced Biomedical Instruments
K842614Carolina X-Ray Co. Simplafloat TableCarolina X-Ray Co., Inc.IXQClass II
K842540Clinicomp R.c.i.Clinicomp, Inc.KPTClass II
K842397Urihesive Sys Male External CatheterConvatec, A Division of E.R. Squibb & SonsKNXClass II
K842396Accuseal Leg Bags & Extension TubesConvatec, A Division of E.R. Squibb & SonsKNXClass II
K842395Sur-Fit Night Drainage Container SetConvatec, A Division of E.R. Squibb & SonsKNXClass II
K842384Ultra-Violet Emitting Sunlamp ProductSola-Tan Intl.FTCClass II
K842257Corpak Urinary Drainage BagCorpak Co.KNXClass II
K842130G.i. Cleansing KitMmi, Inc.FCEClass I
K842124EMG Module, Emg1, W/optional SpeakerEndotek Corp.FAPClass II
K841941Van-Tec Occlusion Balloon CatheterVan-Tec, Inc.KODClass II
K841929Lifemed Lifecoil CathetersLifemed of CaliforniaFKXClass II
K841869Cooper Lasersonics, 8000 Nd.yaglaserCooper Lasersonics, Inc.LNKClass II
K841295Hypothermia Oxygen Warmer-Treatment SysBow/ParmBTTClass II
K834442LED Stimulator Ls-05Teca, Inc.GWEClass II
K842988Vmt Gentle-HalerVortran Medical Technology 1, IncCCQClass I
K842985T- Extension Set T-04-CTico Medical Instruments, Inc.FPAClass II
K842871Hippurate Test ReagentIrvine Diagnostic ServicesJSFClass I
K842869Decarboxylase Test ReagentIrvine Diagnostic ServicesJSFClass I
K842851Ornithine Indole MotilityAnarobe SystemsJSHClass I
K842697Rootman Orbital Surgery Instrument SetDowns Surgical, Ltd.HNRClass I
K842651Commode Chair 98200Guardian Products Co., Inc.ILSClass I
K842570Ludlum 88 Dose CalibratorLudlum Measurements, Inc.KPTClass II
K842555Dhea-S Direct Ria KitBiotecx Laboratories, Inc.JKCClass I
K842505Tdx Rea Iron Diagnostic KitAbbott MedicalCFMClass I
K842419Ivac 280 Volumetric Infusion ControllerYLDRClass II
K842156Serum Iron & Serum Iron Binding CapacityDiagnostic Chemicals, Ltd. (USA)CFMClass I
K842155Serum Iron & Serum Iron Binding CapaciDiagnostic Chemicals, Ltd. (USA)CFMClass I
K842128American Medical Optics PhotokeratoAmerican Medical OpticsHJAClass I
K841767Woodlyn Classic KeratometerWoodlyn, Inc.HLIClass II
K841765Woodlyn Standard Slit Lamp Hssl-StWoodlyn, Inc.HLQClass I
K841764Woodlyn Classic Javal OphthalmometerWoodlyn, Inc.HLIClass II
K841761Woodlyn Classic Slit Lamp Hssl-ClWoodlyn, Inc.HLIClass II