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 3086 of 3528
510(k) clearances, page 3086 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841027Provider Site Prep & Check Strip KitPancretec, Inc.FPAClass II
K840681Daypak System III Catheter Care KitCreative Care Systems, Inc.LJSClass II
K840497Obstetric Pulsar Two Channel TENSSpembly Medical, Ltd.GZJClass II
K845052Paramax Total Protein Reagent TpAmerican DadeCEKClass II
K841391Weber-Stuhmer Hip Prosthesis StemAllo Pro Corp.JDIClass II
K841367Airco Oxygen RegulatorWelding ProductsCANClass I
K841321Air-Neb Nebulizer Compressor UnitAirmed Corp.CCQClass I
K841274Bag-to-Ventilator Selector ValveOhio Medical ProductsBSZClass II
K841272Sickle-Stat Hemoglobin S Screen KitClinical Technology Inc.GHMClass II
K841214Labsystems UniskanLabsystems, Inc.JJQClass I
K841156Vantage EAmerican Sterilizer Co.FRGClass II
K841145Tilt Table 53S & W Enterprises, Inc.INQClass I
K841102Bunn 1000 Oxygen ConcentratorThe John Bunn Co.CAWClass II
K841045Empi Model 984 Basix, TENSEmpiGZJClass II
K841039Cantor TubeInmed Corp.KNTClass II
K841038Blakemore TubeInmed Corp.KNTClass II
K841036Rectal Balloon CathetersInmed Corp.KNTClass II
K841035Ultra Baker Jejunostomy TubeInmed Corp.KNTClass II
K841034Deaver T-Drain & Cattel T-DrainInmed Corp.KNTClass II
K841033Miller-Abbott TubeInmed Corp.KNTClass II
K841000Bet Model 1010Bioelectro TechnologiesGZJClass II
K840984Interdental WedgesHealthco, Inc.DZNClass I
K840971Selective Culture MediumChatham BiologicalJSDClass I
K840970Culture Medium for Pathogenic NeisserChatham BiologicalJTYClass II
K840969Culture Media for Antimicrobial SuscepChatham BiologicalJTZClass II
K840944Infusion Needle IipnMedi Tex, Inc.FMIClass II
K840826Tdx EthanolAbbott MedicalDICClass II
K840818Biopsy ForcepsAmerican Endoscopy, Inc.FCLClass I
K840793Ck/mb Immuno-Isoenzyme Control SerumSeragen Diagnostics, Inc.JJTClass I
K840784Paramax Magnesium ReagentAmerican DadeJGJClass I
K840782Albumin ReagentAmerican DadeCIXClass II
K840781Uric Acid ReagentAmerican DadeKNKClass I
K840779Neonatal Bilirubin ReagentAmerican DadeCIGClass II
K840778Lactate ReagentAmerican DadeKHPClass I
K840772Alcohol & Ammonia Calibrator IIAmerican DadeJITClass II
K840771Alcohol & Ammonia Calibrator IAmerican DadeJITClass II
K840769Paramax Alcohol ReagentAmerican DadeDMLClass II
K840755Minigard Disposable LinersIpco Corp.EYQClass I
K840754Maxishield Incontinence Care SystemIpco Corp.EYQClass I
K840753Ambeze Disposable Incontinence PantsIpco Corp.EYQClass I
K840750Hydroxylapatite Coated Endosseous DentCalcitek, Inc.DZEClass II
K840746Ureteral DilatorAmerican Edwards LaboratoriesKOEClass II
K840727Pentra-Fil IIPentron Corp.EBFClass II
K840708Colistin DiscRemel Co.JTOClass I
K8406862U Penicillin DiscRemel IncJTOClass I
K840677Hdl Ez-Tz3 Cholesterol Reagent KitPreventive Diagnostics Corp.LBSClass I
K840614Rifampin DiscRemel Co.JTOClass I
K840605Laborie Fibreoptic Light CableTridak Division of Indicon, Inc.FFSClass II
K840599Multi-StimtJoanco Medical Electronics, Ltd.GZJClass II
K840562Rex VJeneric Ind.EJHClass II