510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 2486 of 3531
510(k) clearances, page 2486 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K905387Degudent GsDegussa AGEJTClass II
K905319VariousIvoclar North America, Inc.EJTClass II
K905312Duraflo II Heparin Treated Femoral Cannulae ModelsBaxter Bentley Laboratories, Inc.DWFClass II
K905311Duraflo II Heparin Treated Suction Wands Var. Mod.Baxter Bentley Laboratories, Inc.DWDClass II
K905100Hewlett Packard Model 5650C, Cardio Data Mgmt SystHewlett-Packard Co.DQKClass II
K905017Lab-SiteTelos Medical Corp.DQOClass II
K904994Closed System Flush SetArgon Medical Corp.DXTClass II
K904979Avi Model 600 Syringe Pump, Modification3M Avi, Inc.FRNClass II
K904777Series 51 and 53 Disposable Pressure TransducersBaxter Healthcare CorporationDRSClass II
K903733Ica Plasma Hdl and Ldl Measurement SystemInstitute for Clinical ApplicationsLBRClass I
K903697Hawaiian Supracondylar PlateMedpacHRSClass II
K9033449.5 Fr Percutaneous Db Lumen 40Cc Flexi-Cath (Tm)Kontron Instruments, Inc.DSPClass II
K900099The O-Ring System - OrsAttachments Intl., Inc.DZEClass II
K910055Acme Model 8500 Wheelchair ScaleAcme Medical Scale Co.INFClass I
K905836Ultra Wave 101Ako USA, Inc.IROClass I
K905301The Theratest Aca TestTheratest Laboratories, Inc.GFOClass II
K905231Dale Ventilator Tubing Support for Trach. Vent.Dale Medical Products, Inc.CBHClass I
K905199Pacsnet Research ToolkitSiemens Gammasonics, Inc.LMDClass I
K905162Quidel Total Ige Positive Control SerumOrtho-Clinical Diagnostics, Inc.DHBClass II
K904998The Body Cooler SystemCosta / FrenchILOClass II
K904971CT Hilight Advantage IIGE HealthcareJAKClass II
K904821Eliachar Modified Esophageal StentHood LaboratoriesESWClass II
K904725Chlamydia System Software (Css)Kallestad Diag, A Div. of Erbamont, Inc.LJCClass I
K904711Bc 1220 Analog - Implant BodyMinimatic Implant TechnologyDZEClass II
K904692Db 3000 a-Scan SystemOcuserv Instruments, Inc.IYOClass II
K904684Amici Krypton Administration System, ModificationAmici, Inc.IYTClass II
K904051Rich-Mar Model V UltrasoundRich-Mar Corp.IMIClass II
K904028Dcw Modular Proximal Femoral SystemDow Corning WrightLZOClass II
K903805Amici Xenon Administration SetAmici, Inc.IYTClass II
K903448Surgitek Tex-Span Textured Tissue ExpanderMedical Engineering Corp.LCJUnclassified
K903439Defend Latex Exam. Gloves(ambidext/non-Ster/hypoalGlovco Malaysia Sdn BhdLYYClass I
K903135Clini-CalcShasta Logic Corp.BSZClass II
K901548Biomedical Sensors-Shiley Bgm 4000 Intra Blood GasShiley, Inc.CCCClass II
K905856Model 556 MonitorGE Medical Systems Information Technologies, Inc.DSFClass I
K905783Modified Walkmed 400Medfusion, Inc.FRNClass II
K905537Perry Xtenda Cuff Surgical GlovesSmith & Nephew PerryKGOClass I
K905233Moor Laser Blood Flow Monitor Mbf3dMoor Instruments Ltd.GEXClass II
K905232Moor Laser Blood Flow Monitor Mbf3Moor Instruments Ltd.GEXClass II
K905215Immulite (Tm) Automated Immunoassay AnalyzerCirrus Diagnostics, Inc.JJQClass I
K905095Model 3100-21: Quadrature Spine CoilMedical Advances, Inc.LNHClass II
K904996Abuscreen Online Tm for ThcRoche Diagnostic Systems, Inc.LATClass II
K904974Trach CollarRotek Corp.CBHClass I
K904886Vascular Access Port Continuous Infusion SetsFlorida Infusion Services, Inc.FPAClass II
K904806Capd Safelock Transfer Set W/pre-Filled ConnectorFresenius USA, Inc.KDJClass II
K904665Model Iw17.5a Intra Operative TransducerKretztechnik AGITXClass II
K904662Sri Johani Latex Surgeons GlovesTranscorpKGOClass I
K902365Modular Unipolar SystemHowmedica Corp.KWLClass II
K903976Cth Stabilo Total Hip Replacement SystemKinamed IncLZOClass II
K903315IconSiemens Gammasonics, Inc.JWMClass II
K905756Titan Meridian Intersegmental RollertableTitan Technology Intl., Inc.JFBClass II