510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3054 of 3529
510(k) clearances, page 3054 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K843243Companion 492 Oxygen ConcentratorMedtronic, Inc.CAWClass II
K842952Regular Maxithins Body-Shaped MaxiTambrands Inc.HHDClass I
K842891Qca TriglyceridesBD Becton Dickinson Vacutainer Systems PreanalyticCDTClass I
K842752Zeeman 3030 Atomic Absorpt SpectorphotRevvity Health Sciences, Inc.JXRClass I
K842181Beta-Hcg Hemagglutination TestSero-Immuno Diagnostics, Inc.JHJClass II
K840055Dynascope SeriesFukuda Denshi USA, Inc.DRTClass II
K840009Nova 12 Cardiac Output ComputerNova Medical SpecialtiesDXGClass II
K833365Ultra Shape CondomsBarnetts, Inc.HISClass II
K842986Refrax Mounting MediumAnatech, Ltd.LEBClass I
K842953All-Hands Medical Supply Suture RemovalAll-Hands Medical Supply, Inc.HRRClass I
K842911Puck U & Ud Cutfilm ChangersElema-Schonander, Inc.KPXClass II
K842903Sep Programmer for Puck U & Ud FilmchangElema-Schonander, Inc.IZPClass II
K842863Pro-Soft DehydrantAnatech, Ltd.PPMClass I
K842861Pro-Par ClearantAnatech, Ltd.KEMClass I
K842804Diadyn 4Robert Bosch Corp.IPFClass II
K842803Interferenz 4Robert Bosch Corp.IPFClass II
K842707Adp Ndna Ifa TestApple Diagnostic ProductsKTLClass II
K841964Micro Delta & CeltaproComputer Design & Applications, Inc.IYXClass I
K843175Nerve Stimulator Q10Acm SystemsBXNClass II
K843169Cushion-Flex TmLife Design Systems, Inc.BSJClass I
K843066Biotis Cin Agar PlatesOtisville Biotech, Inc.JSIClass I
K843065Biotis Cdc Modified Mcclung-Toabe EggOtisville Biotech, Inc.KZIClass I
K842776Minimum Essential Med W/l-GlutamineSigma Chemical Co.KITClass I
K842542Amer. Pharmaseal Chemonucleolysis TrayAmerican Pharmaseal Div. AhscFMIClass II
K842254Medical Emerg. Stabilizer Object/bodyWalter Ansted Co.
K841312Assure-Breathable Panty Liners/scentPersonal Products Co.HHLClass II
K841311Assure-Breathable Panty Liners/unscentPersonal Products Co.HHDClass I
K841287Duoderm Flexible Hydroactive DressingsConvatec, A Division of E.R. Squibb & SonsFROUnclassified
K840406Microsurgical CO2 Laser Sys - 4100Bio Quantum Technologies, Inc.GEXClass II
K841607American Edwards Labs FlexiscopeAmerican Edwards LaboratoriesHRXClass II
K843146Micro-Temp Pumps & Micro-Temp PadsSeabrook Medical Systems, Inc.ILOClass II
K843119Eti TENS BeltElectro Therapeutic Devices IncGZJClass II
K843116Disposable Skin Marking PenE.M. Adams Co., Inc.FZZClass I
K843102Ava-Neb NebulizerAvatron, Inc.CCQClass I
K843074Dispos. & Sponge Forceps Pean ArteryGreene International Corp.GENClass I
K843016Vinyl Exam Gloves, Non-SterileAbco Dealers, Inc.
K842992Grasshopper - RetractorNorton Texas Medical ProductsGADClass I
K842975Brownie Booth Bb1Weingart, Inc.FTCClass II
K842963Rhys-Davies ExsanguinatorWoodville Polymer Engineering, Ltd.KCYClass I
K842958Boundary Single-Use or GownProcter & Gamble Mfg. Co.FYAClass II
K842898Curity i.v. Start KitThe Kendal Co.LRSClass II
K842896Blom-Singer Low Pressure Voice ProsthesAmerican V. MuellerEWLClass II
K842883Radovan Tissue ExpanderMentorLCJUnclassified
K842854Mueller Hinton BrothAnarobe SystemsJTZClass II
K842850Triple Sugar IronAnarobe SystemsJSHClass I
K842846Sewon Dental Floss FolderSewon IndustryJESClass I
K842844Denti-D Rubber DamFema Corp.EIEClass I
K842809Technicon Ra-1000 Sys, Direct BilirubinTechnicon Instruments Corp.CIGClass II
K842782Physiological Analyzer Cm-710Cybermedic, Inc.BZMClass II
K842775Min. Essential Med. W/l-Glutamine, RibSigma Chemical Co.KITClass I