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 3310 of 3528
510(k) clearances, page 3310 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K802920Inspiron Pulmonary Function AnalyzerC.R. Bard IncBZCClass II
K802348TriaxialJohnson & Johnson Professionals, Inc.JDBClass II
K810319Cordis Stimucord External Neutral StimCordis US Corp.GZBClass II
K810314William Harvey Flowmeter SystemC.R. Bard IncBYMClass I
K810308Arterial Microcollection SetAmerican DadeCHLClass II
K810296Digoxin Ria AssayRia DiagnosticsDONClass II
K810280Dialysate Concentrate for HemodialysisCobe Laboratories, Inc.KPOClass II
K810271Direct Current Bone Growth Stim. an. PadAndover Medical, Inc.
K810263Microprocessor Controlled ElectrocardioHoneywell, Inc.DPSClass II
K8102541.5` Focal Spot Resolution PatternMachlett Laboratories, Inc.IXFClass I
K810240Cliniguard SterileClinipad Corp.KMFClass I
K810237Portable, Battery Operated DefibrillatorHoneywell, Inc.LDDClass II
K810227Model #53110 Disposable AnoscopeWelch Allyn IncFERClass II
K810118Ls1000 Electronic FocusPhilips North America LLCIYNClass II
K810009Disposable Diaphragm DomeMedex, Inc.DRSClass II
K803167Brigham Total Ankle ProsthesisHowmedica Corp.HSNClass II
K802894Cordis Dow C-Dak 1.8Mrc Artific-KidneyCordis US Corp.FJIClass II
K802434Varian V3500 Phased Array UltrasonographVarian Assoc., Inc.IYOClass II
K810209IrrijetAckrad LaboratoriesKYZClass I
K810148AtmosetJEDMED Instrument CompanyETFClass I
K810137Sof-Band High Stretch BandagesJohnson & Johnson Professionals, Inc.FQMClass I
K803110Proteolytic Enzyme ControlAmerican DadeLGPClass II
K802851Gardner Kuphosis DistractorDowns Surgical, Ltd.
K802840Alpha-Antiplasm AssayAmerican DadeLGPClass II
K810384Intermedics Cyberlith I Unipolar CardiacIntermedics, Inc.
K810238Supine Stress SystemO'NeillBXBClass I
K810207Minor Surgery LightCavitron Corp.GBCClass II
K810200Optipore Scrub SpongeBio SyntecEFQUnclassified
K810199Disposable Surgery Caps & HoodsAnago, Inc.FYFClass I
K810158Davol Silicone Sheath Sump DrainC.R. Bard IncGBSClass I
K803178Anspach Menisectomy KnifeThe Anspach Effort, Inc.FZSClass I
K802893Cordis Dow C-Dak 1.3Mrc Artif. KidneyCordis US Corp.FJIClass II
K802790SolvalineSecol Co.KKXClass II
K802082Polaris Spectacle Frames & LensesPolaris Optics USA, Inc.HQYClass I
K810290Ohio Cal-ChekOhio Medical ProductsBXWClass I
K810288Aircast Tennis Arm BandAircast, Inc.IQIClass I
K810275Grab BarsMaddak, Inc.IKXClass I
K810255Mean Pressure MonitorHealthdyne, Inc.CAPClass II
K810243System 86 Computerized Lung Vol. SpiromeCardio Pulmonary InstrumentsBZCClass II
K810241Crystal-BondAmerican OrmcoDYHClass II
K810208Blade SafeInstranetics, Inc.MMKClass II
K810159Bone Mineral Analyzer ControllerLunar Radiation Corp.KGIClass II
K810151Slick Set W/sureloc External ConnectorPolamedco, Inc.BTRClass II
K810150Omnisurg Working Instrument TablePolamedco, Inc.
K810140Dual-Photon Total Body Bone Mineral AnaLunar Radiation Corp.KGIClass II
K810100Breast PumpAmerican Hospital SupplyHGYClass I
K810095Moti ApronMoti Enterprises, Inc.KPYClass I
K810072105Mm Roll Film Fluorogr. Camera, #105Scientex Corp.IZJClass II
K810071Sterile Silicone TubingMedspec Corp.GBSClass I
K810045I.m. Retrograde BladesHogan & HartsonGFAClass I