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 3262 of 3528
510(k) clearances, page 3262 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K812111Pruitt Arterial Occlusion Cholang. CathBionomy, Inc.DYGClass II
K811972Extrasensr Ultrafiltration MonitorExtracorporeal Medical Specialities, Inc.FKPClass II
K812312Sterile Water 4Oz.Superior Plastic Products Corp.JOLClass II
K813072E2502 & E2502b LectroswitchMedtronic, Inc.GEIClass II
K813071E2508 Disposable Handswitching PencilMedtronic, Inc.GEIClass II
K813044Ultrachem Alb, Item #64970HarlecoCIXClass II
K813043Ultrachem Crea Item #64972HarlecoCGXClass II
K813042Ultrachem Gluc-Dh Set, Item #65048HarlecoLFRClass II
K813041Ultrazyme-Gt, Item #64959 & 65032HarlecoJQBClass I
K813040Ultrachem Ca, Item #64975HarlecoCJYClass II
K813039Ultrachem E-Chol, Item #65025HarlecoCHHClass I
K813038Ultrachem Tp, Item #64974HarlecoCEKClass II
K813025Standing FrameBarnett Medical
K813014Protect-O-SealTri-Med, Inc.JOJClass II
K812993Moxalactom 30Mcg Antimicrobial Sus. DiskGeneral DiagnosticsJTNClass II
K812983DsdPm America, Inc.JQWClass I
K812902Acupress VibratorEicona Corp.IROClass I
K812888Syringe, PistonFrisco Products, Inc.FMFClass II
K812865Quantumatic Dual-Wavelength SpectroAbbott MedicalJJQClass I
K812820Chang MediumHana Biologics, Inc.KITClass I
K812817Neutral Duffered Forma-ScentMeridian Diagnostics, Inc.IFPClass I
K812806Kt-1000 DeviceMedmetric Corp.LYHClass I
K812567ReliefAmerican Pharmaceutical Co., Inc.LKXUnclassified
K812566Universal Suture PasserOrtho Pared Instruments, Inc.GDLClass I
K812411Immuno-Cell Immuno-Sep KitKallestad Laboratories, Inc.JCFClass I
K812398LinusFischer Imaging Corp.IYOClass II
K812315Bactec Resin Culture Med. 16ABD Becton Dickinson Vacutainer Systems PreanalyticMDBClass I
K812122Multi Clot-#819Volu Sol Medical IndustriesJPAClass II
K812090Lorenz Blood Gas AnalyzerLorenz InstrumentsCHLClass II
K811924Pre-Filled Syringe & Cystoflo Urinary BgTravenol Laboratories, S.A.KODClass II
K813018Oxytron Oxygen GeneratorElmore Technology Corp.CAWClass II
K813012Sterile Basin SetsMedspec Corp.LDQ
K813003P.p.p. Treatment CabinetPrecision Professional ProductsERAClass I
K813001Fibri-Filter 20Tri-Med, Inc.FPBClass II
K812981Fluven Sets (Ext-1, Ext-2, Ext-3, Ext-4)Venusa Ltd.FPKClass II
K812980Ma-2 VentilatorBio-Medical Repair, Inc.CBKClass II
K812978Uric Acid System Pack TestBoehringer Mannheim Corp.KNKClass I
K812972Ra Latex TestOxoid U.S.A., Inc.DHRClass II
K812970S/p Capillary Tubes, Heparinized (3A)American DadeGIOClass I
K812969S/p Capillary Tubes, Heparinized (2A)American DadeGIOClass I
K812968Fiax Rheumatoid Factor Test KitIntl. Diagnostic TechnologyDHRClass II
K812967Accurate BetaOrganon LLCJHJClass II
K812952Rion Audiometer Aa-68Rion Acoustic Instruments, Inc.GWOClass II
K812951Rion Audiometer Aa-67Rion Acoustic Instruments, Inc.GWOClass II
K812946Tronzo HipZimmer GmbHDXQClass II
K812945Liquilyme Bun ReagentAmresco, Inc.LFPClass II
K812943Slick Endotracheal TubePolamedco, Inc.BTRClass II
K812939In-the-Ear Model 101MDanavox, Inc.ESDClass I
K812938In-the-Ear Model 821Danavox, Inc.ESDClass I
K812937Behind-the-Ear Model 115Danavox, Inc.ESDClass I