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 3383 of 3526
510(k) clearances, page 3383 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K792138Smac (Sequential Mult. Analysis Comp.Fisher Scientific Company L.L.C.CEKClass II
K792131Temporary Transvenous Pacmker. ElectrodeStanco Medical, Inc.DYBClass II
K792130Transvenous Balloon Cath. Intro. KitStanco Medical, Inc.DYBClass II
K792129Emit Clinical Processor-Cp 5000Syva Co.JQPClass I
K792118Air-Shields ResuscitatorsNarco Air-ShieldsBTMClass II
K792117Air-Shields Heart Rate MonitorNarco Air-ShieldsDRTClass II
K792100Grasping Forcep (W/four Prongs)Eder Instrument Co, Inc.GENClass I
K792098Gas-Trak Blood Gas ControlUnited Diagnostics, Inc.JJSClass I
K792097Dryden Bacteria FilterDryden Corp.CAHClass II
K792087Microflame PhotometerGilford Instrument Laboratories, Inc.JJOClass I
K792082Gavage Feeding SetMedical Devices Inc.EYNClass II
K792081Spectra Central Pt Monitoring SysAmerican Optical Corp.DSIClass II
K792051Ckg CardiokymographCardio Kinetics, Inc.DSBClass II
K792040Bard Biomedical Printed Silver ElectrodeC.R. Bard IncDRXClass II
K792038Nelaton CatheterAmerican Hospital SupplyKODClass II
K792037Non-a-ThermLabarge, Inc.KODClass II
K792026Wrights Rapid StainMcb Manufacturing Chemists, Inc.IAFClass I
K792018Silicone Rubber-Bi Nasopharyngeal AirVesta, Inc.BTQClass I
K792014Lancer L-Ina Buffer, Polymer, Wash SoluSherwood Medical IndustriesJZWClass I
K792013Lancer L-Ina Human Reference SerumSherwood Medical IndustriesJIXClass II
K791991Strep-SpecMicro-Media Systems, Inc.JSSClass I
K791979Technicon Fast-Lc Sys. Anticonvu DrugsTechnicon Instruments Corp.DPEClass II
K791963Usci Mullins Transseptal Catheter Intro.C.R. Bard IncDYBClass II
K791961Extracorporeal's Model Ex-85 DialyzerExtracorporeal Medical Specialities, Inc.FJGClass II
K791947Shiley Cardioplegic Solution Del SetsShiley, Inc.DWFClass II
K791938Atmos ENT Patient Chair #5JEDMED Instrument CompanyETL
K791937Atmos ENT Patient Chair #1JEDMED Instrument CompanyETL
K791933Conversion Contractor Timer KitAdvanced Instrument Development, Inc.IZOClass I
K791932Ams Enterobacteriacease CareVitek Systems, Inc.JSSClass I
K791928Antibody to Native Deoxyribonuclease KitKeith E. AbbottDHNClass II
K791927Heart Rate Computer Strip ChartStanford Assoc., Inc.JOMClass II
K791899Cycler Sets Mod. #5C4143, 5C4144, 5C4145Travenol Laboratories, S.A.KDJClass II
K791897Bacto-HattsDifco Laboratories, Inc.GMTClass II
K791873Usci Safe-T-Cloth Thermodilution Cat.C.R. Bard IncKRBClass II
K791872Lap SpongesCarwild Corp.EFQUnclassified
K791822Bioguard Infusion Line FilterUnited States Surgical, A Division of Tyco HealthcFPBClass II
K791777Corning Glycosylated Hemoglobin SetCorning Medical & ScientificLCPClass II
K791747Htsh Neonate Ria Diagnostic KitAbbott MedicalJLWClass II
K791680Pope Umbrella TubeXomed, Inc.ETDClass II
K791632Compu-ScanHittman Medical SystemsDSIClass II
K791618Torch Bio-Bead Screen KitLitton BioneticsGLZClass II
K791614Hsv Bio-Bead Screen KitLitton BioneticsGQNClass II
K791612Cmv Bio-Bead Screen KitLitton BioneticsGQHClass II
K791611Toxo Bio-Bead Screen KitLitton BioneticsGLZClass II
K791610Rubella Bio-Bead Screen KitLitton BioneticsGOLClass II
K791566Model as* 6C Infusion PumpBaxter Healthcare CorporationFRWClass I
K791411Coaxial Dual Flow CatheterTerumo America, Inc.KOCClass II
K791293Battery Powered Syringe Infusion PumpHarvard Apparatus, Inc.FRNClass II
K791216Centria Vitamin B12 Folate Radio SetVentrex Laboratories, Inc.CDDClass II
K790406Delta D-750 ThermaflowDelta Medical IndustriesDTZClass II