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 3174 of 3528
510(k) clearances, page 3174 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830243Abduction PillowWarm & Form, Orthopedic MaterialsIOZClass I
K830089Burn DressingAction Medical Systems, Inc.NADClass I
K823885Selective Legionella MediaGibco Laboratories Life Technologies, Inc.JSJClass I
K823859Middlebrook 7H10 Agar Base-LowphGibco Laboratories Life Technologies, Inc.MJDClass II
K823848Crafton Arthroscopy Pump Ap-10Gambro, Inc.HRXClass II
K823833Micro Stix #011-010-5000 & Holder#5100Dynatech Corp.LIBClass I
K823727Spectron Primary Stem Femoral ProsthesRichard'S Medical Equip., Inc.JDIClass II
K823722Spectron Long, Straight Femoral ProsthesRichard'S Medical Equip., Inc.JDIClass II
K837105Elder Psoralite, Series 43000Elder Pharmaceuticals, Inc.
K830459Behind the Ear Hearing Aid Omni #OsOmni Hearing SystemsESDClass I
K830423Syringe Driver Ms-16Intermedics, Inc.FRNClass II
K830402Hearing Aid, #Ue7-DUnitron Industries, Inc.ESDClass I
K830384Legionella Selective SupplementsGibco Laboratories Life Technologies, Inc.JSJClass I
K830318Paramax Analytical SysAmerican DadeJJEClass I
K830303800 BlueElectone, Inc.ESDClass I
K830252Dipchex Dip-Slide Culture SysGranite Diagnostics, Inc.JXAClass I
K830228Otological Ventilation Tubes-VariousMicromedics, Inc.ETDClass II
K830223Fecal Occult Slide Test KitCambridge Chemical Products, Inc.KHEClass II
K830208Beta-Cap D AdapterQuinton, Inc.FKXClass II
K830130Miniature Ion Selective ElectrodesIonetics, Inc.JSGClass I
K830106UnicideNorth Pacific Dental, Inc.LFEClass II
K830058Myograph 2000Prothia USA, Inc.BXNClass II
K823884Paragon Immunoelectrophoresis ReagentBeckman Instruments, Inc.CFFClass II
K823782Respitrace SystemRespitrace Corp.BZKClass II
K823466Auto-TENS Model III Dual Channel ReplaceCbc Corp.GZJClass II
K823135Double Lumen Subclavian CatheterAbbott MedicalLFJClass II
K837139Models Eurosun 2400 and 800Eurosun Scaenda Sol
K837125System 900 Two Room Remote FibersCoherent Radiation Laboratories
K828326UnknownLasertek Oy
K828328Ultrascan Digital A/system IIICooper Lasersonics, Inc.
K830332Budde-Halo RetractorOhio Medical Instrument Co., Inc.GZTClass II
K830284Fh 101, Fh 202 & Fh 303 Fiber HemofilterGambro, Inc.KDIClass II
K830450Delmed IV ContainerDelmed, Inc.KPEClass II
K830406Non-Sterile Catheter Repair KitsEvermed, Inc.LJSClass II
K830377Secura Set Primary Admin. SetDiatek, Inc.FPAClass II
K8303603M Osteotomy Guide3M CompanyHWTClass I
K830355Secura IV Volumetric Infusion PumpDiatek, Inc.FRNClass II
K830325Tiger PulseBertone & Assoc.GZKClass II
K830300Frehan Inc. i.v. Filter HolderSaxnor Corp.KMKClass I
K830256Non-Sterile Broviac Parenteral Alimi-Evermed, Inc.LJSClass II
K830188Osmocel +Hematology Marketing Assoc.GIFClass I
K830187Focus FluidHematology Marketing Assoc.EIFClass I
K830164Densitometric Inhalent Profile SllerMast ImmunosystemsDGCClass II
K830117EndometNorth Pacific Dental, Inc.EMAClass II
K830115Paper PointsNorth Pacific Dental, Inc.EKMClass I
K830114Gutta Percha PointsNorth Pacific Dental, Inc.EKMClass I
K830109CimpatNorth Pacific Dental, Inc.EMRClass I
K830105VitathylNorth Pacific Dental, Inc.EATClass II
K830087Intramedullary RodThe Deca Co.HSBClass II
K830000Vascular-Access-PortNorfolk Medical Products, Inc.LJTClass II