510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3227 of 3528
510(k) clearances, page 3227 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K821438Red Dot Monitoring Electrodes #2260/653M CompanyDRXClass II
K821368Models 78504A & 78508A Patient Mon. SysHewlett-Packard Co.DRTClass II
K821349Conphar Foerster ForcepsConphar, Inc.GENClass I
K821288Tube Occulding Forceps 7Conphar, Inc.GENClass I
K821232One Hand Aneroid SphygmomanometerAbco Dealers, Inc.DXQClass II
K821159In-Line Oxygen Monitoring SystemG.D. Searle and Co.DRYClass II
K821004Medtronic S3 Tm SystemMedtronic, Inc.DYGClass II
K820995Magne-Field 400D Osteo-Bio-Netic SysLudek Optics, Inc.KROClass II
K820959Blood Flow AnalyzerBiofax Medical Instrumentation Co.DSBClass II
K820194Cardiac Catherization Lab MicroprocessCompu-Cath Corp.DXGClass II
K821410Corpak-Monitor Enteral Feeding ContainCorpak Co.KNTClass II
K821409Corpak-Enteral Feeding ContainerCorpak Co.KNTClass II
K821408Phenobarbital Fluorescent ImmunoAmerican Diagnostic Corp.LETClass II
K821397Adult Incontinet BriefJohnson & Johnson Professionals, Inc.EYQClass I
K821334Omed Fabric Instrument Covers-RadiopaqOmega-Med Intl., Inc.
K821315Dowflow Enzymatic Triglycerides DetermThe Dow Chemical Co.CDTClass I
K821305Prolactin (125-I) Radioimmunoassay KitBD Becton Dickinson Vacutainer Systems PreanalyticCFTClass I
K821297Graves SpeculaConphar, Inc.HDFClass I
K821291Pederson Vaginal SpeculaConphar, Inc.HDFClass I
K821222Goldsmith & Revere Tenary AlloyGoldsmith & Revere, Inc.EJJClass II
K821202Hemoglobin Reagent SetOmega Medical ElectronicsGKKClass II
K821184Spin Chem Reagents & StandardsSmithkline Diagnostics, Inc.JIYClass I
K821168Disposable Urinary Legbag W/strapMedical Marketing GroupKNXClass II
K821165Sonic Model 8711 Hearing AidSpec Systems, Inc.ESDClass I
K821155Dental Floss HolderEric L. SmithJESClass I
K821080Hand KeratoscopeMedical Equipment Designs, Inc.HLRClass I
K821077ConpharConphar, Inc.EGNClass I
K821015Care Model Ip 4500 Auto ScannerrCare Monitoring SystemsDRTClass II
K820954Scimed Model Sc 3000Scimed Life Systems, Inc.DTPClass II
K820541MicrolyteKone Instruments, Inc.JJFClass I
K821404Light Weight Aluminum WalkerManuco Manufacturing Co., Inc.ITJClass I
K821369Titanium Aufranc-Turner Ats Hip SysHowmedica Corp.JDIClass II
K821342Metal Backed Acetabular ComponentIntermedics OrthopedicsJOLClass II
K821336Transendoscopic Injection Catheter TeiSounson Research Co., Inc.KNYClass II
K821319Sero/tex RF TestTexas Immunology, Inc.DHRClass II
K821311Espree' Breathing Circuit (W/accessEsp Plastics, Inc.CAIClass I
K821309Espree', Breathing BagEsp Plastics, Inc.BTCClass I
K821308Espree' Guedel Espree Berman AirwayEsp Plastics, Inc.CAEClass I
K821247Accudex Reagent StripsMiles Laboratories, Inc.CGAClass II
K821243Endotracheal TubeLife-Line Products, Inc.BTRClass II
K821242Response Liquid Ligand Assay SerumBeckman Instruments, Inc.JJYClass I
K821240Liquid-Stat Liquid Enzyme ReagentBeckman Instruments, Inc.CGSClass II
K821237Neuromatic 2000Disa ElectronicsIKNClass II
K821234Riagen B-Hcg RiaBiogenex Laboratories, Inc.JHIClass II
K821225Albumin ReagentHi Chem, Inc.CIXClass II
K821214Uric Acid Reagent Set(enzymaticOmega Medical ElectronicsKNKClass I
K821180TracelonTerumo Medical Corp.BTRClass II
K821177Bite StickAbco Dealers, Inc.FMAClass I
K821143Disposable Thumb ForcepsMedcare ProductsGENClass I
K821043Sterile Patient Exam. GlovesPhoenix Glove Co.FMCClass I