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 2382 of 3531
510(k) clearances, page 2382 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K921176Vitek Immunodiagnostic Assay SystemVitek Systems, Inc.CEPClass I
K921012Precise Chromatographic Immunoassay for HcgBD Becton Dickinson Vacutainer Systems PreanalyticLCXClass II
K920921Elisa Tube Prolactin Test KitBio Clinic Co.CFTClass I
K920920Elisa Tube Lh Test KitBio Clinic Co.CEPClass I
K920787Temafloxcin, 5Mcg, Sensi DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K920786Loracarbef 30Mcg, Sensi DiscBD Becton Dickinson Vacutainer Systems PreanalyticJTNClass II
K920416Supplementary Reagents for Enzygnost/tmbBehring Diagnostics, Inc.LIBClass I
K920372Acs Total Ige ImmunoassayCiba Corning Diagnostics Corp.DGCClass II
K920246Sensormedics Model 922 SpirometerSensor Medics Corp.BZGClass II
K920201Titanium Alloy Songer Cable SystemSofamor Danek Mfg., Inc.JDQClass II
K915558Ias Anesthesia MaskIasBSJClass I
K915454Chlamydia Trachomatis Specimen Collection KitMedical Packaging CorporationLIOClass I
K915135Synelisa Tgab/tmabElias U.S.A., Inc.JZOClass II
K915134Synelisa TgabElias U.S.A., Inc.JZOClass II
K915133Synelisa TmabElias U.S.A., Inc.JZOClass II
K915129Catheter with Introducer and SyringesUtah Pioneer Medical, Inc.GCAClass II
K911627Immunodot Borrelia (Lyme) TestGeneral Biometrics, Inc.LSRClass II
K921272Activity ChairRifton Equipment for the HandicappedINNClass I
K921086Wom Laparoflator ElectronicW.O.M. GmbHGCJClass II
K921084The ExcelsiorRehab Technology, Inc.IPLClass II
K920952Vitek Immunodiag Assay Syst(vidas) Ferritine AssayVitek Systems, Inc.DBFClass II
K920918Tmb Chromogen/substrate Reagent SetBio Clinic Co.JHIClass II
K920826Human Chorionic Gonadatrophin and Uncon. EstriolEastman Kodak CompanyJJYClass I
K920585Mat Table, 8100 Series Mat PlatformTri W-G, Inc.INQClass I
K920408Deseret Guidewire Introducer IIIBD Becton Dickinson Vacutainer Systems PreanalyticDQOClass II
K920407Deseret Guidewire Introducer IIBD Becton Dickinson Vacutainer Systems PreanalyticDQOClass II
K920382Flexicair Low Airloss Therapy UnitSupport Systems Intl.IOQClass II
K920050Biolex Wound Gel,Catalina Biomedical Corp.MGQUnclassified
K915897FplWrm ComputersIKEClass I
K915420Hemagen Ena [Jo-1] Kit (Eia Method)Hemagen Diagnostics, Inc.LLLClass II
K915278Cdg Gait Analyses SystemWrm ComputersJFCClass I
K914679Prodigy Nd:yag Surgical Laser SystemXintec CorporationGEXClass II
K913642The Bodyguards Plus Hypo Allergenic Latex Exam GloT.K. Glove Products Co., Ltd.LYYClass I
K912075C-Section TrayMedical Device Inspection CompanyKNAClass II
K920681Avi Model 285Ci Infusion Pump3M CompanyFRNClass II
K920680Avi Model 275Ci Infusion Pump3M CompanyFRNClass II
K920635E-Z Set/minicath Infusion SetsBD Becton Dickinson Vacutainer Systems PreanalyticFOZClass II
K920588Avi Model 3000 Infusion Pump3M CompanyFRNClass II
K920572Uniscan 24 ECG RocorderUniscan, Ltd.DSHClass II
K920393Mu125m Mobile X-Ray SystemShimadzu Medical SystemsIZGClass II
K920306Opti-Mol Filtered Puncture PinAutomatic Liquid Packaging, Inc.BTTClass II
K920126Mrt-50 Flexible Body CoilToshiba America Mri, Inc.LNHClass II
K920114CO2 Insufflator High Flow Electronic InsufflatorSpiess Design, Inc.HIFClass II
K920074Arjo Century Scales with RemoteArjo-Century, Inc.FRWClass I
K915495Deseret Positional Suture WingBD Becton Dickinson Vacutainer Systems PreanalyticKMKClass I
K915372Manual Surgical Instrments for LaparoscopyUnisurge, Inc.GCJClass II
K915367Hdrs-1 SystemPrecision Radiation Measurement, Inc.JAQClass II
K915362Vortech's Film Digitizer, Fd-1Vortech Data, Inc.KPRClass II
K915286Lap Tissue Collection BagBaxter Healthcare CorporationGCJClass II
K914988500 InfuserExcel Medical, Inc.FRNClass II