510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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
46,069 of the 176,466 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
20262,669
176,466 records, page 2641 of 3530
510(k) clearances, page 2641 of 3530
K numberDeviceApplicantProduct codeClassDecision date
K892325Non-Sterile Exam GlovesAnsell, Inc.LYYClass I
K892218Endo-SpongeEndovationsMNLClass I
K892183Maytex Latex Examination GlovesMaytex CorpLYYClass I
K892130Durapro (Patient Examination Gloves)Perfekta Intl., Ltd.LYYClass I
K892106Sterile Exam GlovesAnsell, Inc.LYYClass I
K892104Patient Examination Gloves (Latex)Hartalega Sdn BhdLYYClass I
K892102Protex (Patient Examination Gloves)Hon Shan Development, Ltd.LYYClass I
K892094Patient Examination Gloves (Latex)Tekmedic (M) Sdn BhdLYYClass I
K892082Maytex Non-Sterile Latex Exam GlovesMaytex CorpLYYClass I
K892037Patient Examination Gloves (Latex)Kindly Assoc., Inc.LYYClass I
K891867Patient Examination Gloves (Latex)Johor Bahru Emulsion Industries Sdn. Bhd.LYYClass I
K891863Patient Exam Glove (Mfg. Dalian Latex & Jin Zhou)China Xinxing Corp., Ltd.LYYClass I
K891841Latex Exam Gloves (Mfg. Yeou Jih Industrial Co.)Neo-Sigma, Inc.LYYClass I
K891821Patient Examination Gloves (Latex)Koon Seng Sdn BhdLYYClass I
K891687Extracorporeal Circuit with Bio-Active SurfaceMedtronic Blood Systems, Inc.DTZClass II
K891686Lib System, Baby/adult DiaperIntera Corp.EYQClass I
K891643Samboro Latex Patient Examination GlovesKtp Gloves Industrial Corp.LYYClass I
K891620Patient Examination Gloves (Latex)Albors-Menconi Latex Corp.LYYClass I
K891440Patient Examination Gloves (Latex)Interpro Intl., Inc.LYYClass I
K891438Patient Examination Gloves (Latex)Interpro Intl., Inc.LYYClass I
K891437Patient Examination Gloves (Latex)Amerimed US Corp.LYYClass I
K891436Patient Examination Gloves (Latex)Amerimed US Corp.LYYClass I
K891342Patient Examination Gloves (Latex)Tiger Marketing, Inc.LYYClass I
K891225Optional Probe of Canon IOL Estimator Ku-1Canon Medical Components U.S.A., Inc.IYOClass II
K891008Vestibular Ocular Reflex Test Equipment(vorteq)Micromedical Technologies, Inc.LXVUnclassified
K890651Latex Examination GloveTianjin Tang GU Latex FactoryLYYClass I
K890644Medtronic Model 5866-45 Sizing SleeveMedtronic, Inc.DTBClass III
K890629Esophageal OvertubeGastrotech, Inc.FEDClass II
K890207Interventional Products - Guide WiresE-Z-EM, IncDQXClass II
K885256Medilog Excel ECG Analysis SystemOxford Medical, Inc.DSIClass II
K884423Horizon Display Controller Part # 266-200-010Mennen Medical, Inc.DXJClass II
K892405Needlepoint GuardUrological Assoc. of Grand Island, P.C.FMFClass II
K891989Argedent 52 (Dental Alloy)Argen Precious Metals, Inc.EJTClass II
K891226Vascular Access Port Continuous Infusion SetInfucare Products, Inc.FPAClass II
K891187Tecnol Naso-Gastric Tube HolderTecnol New Jersey Wound Care, Inc.BSSClass II
K891064Espe CapmixEspe GmbH (US)EFDClass I
K890284Urodec 500Ferguson MedicalFESClass II
K893248Alpha MallardAlpha Unlimited, Inc.INIClass II
K893168Spinalator Js-1100 Traction UnitThe Spinalator Co.ITHClass II
K893033Mini-Diamond KnifeL.A.B. InstrumentsGDXClass I
K892927Proximate Linear Cutter Thick Tissue Inst.Ethicon, IncGAGClass II
K892869Angiotec Zx Digital Image ProcessorAndros Analyzers, Inc.LLZClass II
K892669Comfortrac, Ct90 & Ct100 Bi-PhasicsComfortrac SystemsISAClass I
K892351Magnilink System 602Coburn Optical Ind., Inc.HJGClass I
K892350Magnilink System 402/5Coburn Optical Ind., Inc.HJGClass I
K892349Magnilink System 209Coburn Optical Ind., Inc.HJGClass I
K892348Magnilink System 201Coburn Optical Ind., Inc.HJGClass I
K892347Magnilink System 101Coburn Optical Ind., Inc.HJGClass I
K891917Ortho-J, Inc. Bek-Js-004Ortho-J, Inc.JEBClass I
K891909Light-Touch/gs 905250 Nd:yag Laser Micro Pro EndosLifestream Int'L, Inc.GEXClass II