510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3486 of 3526
510(k) clearances, page 3486 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770660Analyzer, Centrifugal, Il Multistat IIIInstrumentation Laboratory Co.
K770655Latelet Determibation Kit, Ul 800BD Becton Dickinson Vacutainer Systems PreanalyticGJPClass II
K770654Un, UV Delta Test AssayBD Becton Dickinson Vacutainer Systems PreanalyticCDQClass II
K770645Spectrophotometer, Model 751Instrumentation Laboratory Co.JXRClass I
K770643Creatinine Test, Super SeventeenHycel, Inc.CGXClass II
K770641Mini-Coner TmMedical Testing System, Inc.KNAClass II
K770640Graphite Atomizer, Hga-76BRevvity Health Sciences, Inc.
K770639Detector, Ir, Model Gc-33Peokin-Elmer Corp.KZQClass I
K770638Detector, UV, Molel Gc-55Peokin-Elmer Corp.KIEClass I
K770413Cushions, Denture Adhesive, All-DayCombe, Inc.EHSClass II
K771117Centria Cortisol RiaClinical Diagnostics, Inc.CGRClass II
K770746Panel, Identification, Strep, Micro-IdMicro-Media Systems, Inc.JSEClass I
K770745Panel, Gnf, Micro-IdMicro-Media Systems, Inc.JSWClass I
K770637Mercury/hydride System Mhs-1Revvity Health Sciences, Inc.DOPClass I
K771046Vena Cava Umbrella Filter, Model 7321Edwards LaboratoriesDTKClass II
K771045Blades, ScalpelAmerican Safety Razor Co.GESClass I
K771029Multisonic (Deluxe) Code TdmQualitoneESDClass I
K770965Human Reference SerumKallestad Laboratories, Inc.
K770940Total Thyroxine (Ria) Reagent SetThe Dow Chemical Co.CDXClass II
K770919Phenobarbital Analytical Test PacksE.I. Dupont de Nemours & Co., Inc.DLZClass II
K770799Tray, Irrigation, Sterile, BasicLukens Corp.KKXClass II
K770796Skin Scrub Prep SetLukens Corp.KKXClass II
K770740Radioassay Tubes & Radioassay Tube CapsG.D. Searle and Co.JJJClass I
K770739Serum Set, Thyroid ControlG.D. Searle and Co.CDPClass II
K770738Reagent, T-3 UptakeG.D. Searle and Co.CDPClass II
K770737Reagent Set, T-4, CpbG.D. Searle and Co.CDXClass II
K770732Reagent System, Progesterone, AriaBD Becton Dickinson Vacutainer Systems PreanalyticJLSClass I
K771026Huang Vein Holder, #21-8011Cerenovus, Inc.DWSClass I
K771011Articulating PaperParker Laboratories, Inc.EFHClass I
K770997Pro-CareYoung Dental Manufacturing Co 1, LLC.JEQClass I
K770990Dental Plaque Disclosing AgentEvident Dental Co., Ltd.QJCClass I
K770967Syringe, Endodontic, W/perforated NeedleNational Patent Development Corp.EICClass I
K770951Cardiac Pacers W/narrow Pulse WidthCordis US Corp.DXYClass III
K770894Neuro-Sorb PattiesInstranetics, Inc.HBAClass II
K770881Generator, Pulse, Bipolar 3608Cardiac Pacemakers, Inc.DXYClass III
K770880Generator, Pulse, Unipolar, #508Cardiac Pacemakers, Inc.DXYClass III
K770749Toothbrush, ReachJohnson & Johnson Professionals, Inc.EFWClass I
K770596ConnectorsAbco Dealers, Inc.FPKClass II
K770523Needle, Biopsy, Boyd, LungCook, Inc.
K770498Preserve Lubricant Code No. 43=4035Cerenovus, Inc.KMJClass I
K771020Spinal Surgery FrameMizuho Orthopedic Systems IncJEBClass I
K771006Modified Podiatry ProductsDentronix, Inc.HTZClass I
K771005New Podiatry ProductsDentronix, Inc.HTZClass I
K771003Lieberman Polack Double Corneal ForcepsEdward Weck, Inc.HNRClass I
K770955MiraclelensM.R.M. Optics, Inc.HQGClass I
K770926Suspension Saline, Api 20EAnalytical Products, Inc.JTOClass I
K770918Liqui Sol T4 Ria Test KitDamon Corp.CDPClass II
K770916Tygon Pac-Monitoring Lines & Fluid AdminNorton Performance Plastics Corp.FMGClass II
K770861Surgical Coldlight, Ax8Affiliated Hospital Products, Inc.FTDClass II
K770787Relaxation Course Model 1000Cybernetic Medical, Inc.HCCClass II