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 3162 of 3528
510(k) clearances, page 3162 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830711Trachestomy & Nasal Suctioning Kit #-Intertex MedicalGBZClass I
K830707Acufex Universal Leg HolderAcufex Microsurgical, Inc.FWZClass I
K830607Suction ReservoirSil-Med Corp.GCYClass I
K830510Bbl Strep Grouping KitBD Becton Dickinson Vacutainer Systems PreanalyticGCYClass I
K830788Central Vein Catherization Kit-14-690-Norton Performance Plastics Corp.DQOClass II
K830697Venes High Compression Medical Stock-Futuro Div. Jung Corp.DWLClass II
K830453IV Administration Sets - Mvp InfusionZiehm International, Inc.FPAClass II
K823898Model Mf..d & Mx..d Pacemaker LeadsOscor Inc.DTBClass III
K823897Model Sf. D&sx.d Pacemaker LeadsOscor Inc.DTBClass III
K823896Model Ff..d & Fx..d Pacemaker LeadsDr. Ing. P. Osypka, GmbHDTBClass III
K823895Model RF. D&rx..d Pacemaker LeadsOscor Inc.DTBClass III
K823894Model Rz Pacemaker Lead VariousDr. Ing. P. Osypka, GmbHDTBClass III
K823893Model Mz Pacemaker Lead-VariousOscor Inc.DTBClass III
K823892Model Sz Pacemaker Lead-VariousDr. Ing. P. Osypka, GmbHDTBClass III
K823889Model Jy Pacemaker Lead - VariousOscor Inc.DTBClass III
K837336Verasun Radiation Therapy Simulation SystemCgr Medical Corp.
K837314Sdl-10 Diagnostic UltrasoundShimadzu Corp.
K837245Transparent X-Ray Compensation FilterVictoreen, Inc.
K837084Ultrasound Equipment Model Sdl-100AElscint, Inc.
K831169Top-Fill BagBiosearch Medical Products, Inc.KNTClass II
K831159I/a KitStaar Surgical AGJSMClass I
K831150Panasonic Model Hv-5Panasonic Co. Div. Matsu Elec. Corp. AmericaFLLClass II
K831121Curity Leg BagThe Kendal Co.KNXClass II
K831089Infusion PumpBeech Medical, Inc.FLLClass II
K831088Mini-Vol i.v. SetBeech Medical, Inc.FPAClass II
K831087Mini-Vol Extension SetBeech Medical, Inc.FPAClass II
K831079LiquipetteThe Kendall Company Div. of Tyco Healthcare GroupGJGClass I
K831076Compression SystemKirschner Medical Corp.JDOClass II
K831074Oscar Color Vision TesterCarl Zeiss, Inc.HITClass I
K831059P & T MediumAmerican Micro ScanJSMClass I
K831056Defibrillator Vpd 545Life Science Instrumentation, Inc.LDDClass II
K831043Andrews Remote Chuck DrillMizuho Orthopedic Systems IncHXYClass I
K830995Pocket SpirometerP.K. Morgan Instruments, Inc.BZKClass II
K830977Helena Biostrip PHelena Laboratories, Corp.JIRClass I
K830946Male External CatheterPost Medical, Inc.KNXClass II
K830943Prefilled Respiratory Therapy VialAutomatic Liquid Packaging, Inc.CAFClass II
K830928Ventrex Enzyme Tsh KitVentrex Laboratories, Inc.JLWClass II
K830895Single Use Nebulizer, Adjust. Air-Airlife, Inc.CAFClass II
K830843Blood Gas Solutions & Co-Oximeter Solu-Rna Medical Corp.JKTClass I
K830829Coronary Guiding CatheterAdvanced Cardiovascular Systems, Inc.DYBClass II
K830828Implantable Pacing Lead Ccs Model Sv-101Cardiac Control Systems, Inc.DTBClass III
K830813French Percutaneous Sheath IntroducerNorton Performance Plastics Corp.DYBClass II
K830811Aseptic Fluid Transfer SystemSteridoc Corp.KQQClass II
K830802Loop RetrieverVan-Tec, Inc.OCZClass II
K830776Microfil Contouring InstrumentsAlmore Intl., Inc.EIYClass I
K830775Facebow for Balance ArticulatorAlmore Intl., Inc.KCRClass I
K830773Markley Threaded WireAlmore Intl., Inc.EBLClass I
K830770Contrast Sensitivity EquipmentCadwell Laboratories, Inc.HLXClass II
K830755i.v. Sets Walrus Brand Various Configur-Medical Parameters, Inc.FPAClass II
K830728Cardiovascular Disposable ProductsElectromics, Inc.DWFClass II