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 3284 of 3528
510(k) clearances, page 3284 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K811745Virgo Ipa for Detection of PhenytoinElectro-Nucleonics Laboratories, Inc.DIPClass II
K811744Virgo Ipa for Detection of GentamicinElectro-Nucleonics Laboratories, Inc.LCDClass II
K811739Entri Enteral Feeding PumpBiosearch Medical Products, Inc.FRNClass II
K811726Leksell Stereoactic SystemDowns Surgical, Ltd.LHFClass II
K811725Tbg Diagnostic KitImmuno Assay Corp.CEFClass I
K8117242M 9810 Microwave OvenTravenol Laboratories, S.A.LHFClass II
K811714Hep-2-Crithidia Luciliae Ana Test KitScripps-Miles, Inc.DHNClass II
K811709Quantimune Estriol RiaBio-RadCGIClass I
K811700Circuit, BreathingMarquest Medical Products, Inc.CAIClass I
K811679Silastic Tendon Passer H.p.Dow Corning Corp. Healthcare Industries MaterialsHWQClass I
K811678Gambro Water Purification Monitor WrdGambro, Inc.FIPClass II
K811670Steri-Lok Dual Purpose Packaging/84003M CompanyFRGClass II
K811638Datascope Internal Defibrillator PaddlesDatascope Corp.LDDClass II
K811633Ciras Ultrasonic Scanning SystemAusonics Pty, Ltd.IYOClass II
K811625Prep-Site Protective Dressing WipeAcme United Corp.KMFClass I
K811591B-D Drake Willock #7000 Series UltrafBD Becton Dickinson Vacutainer Systems PreanalyticFKPClass II
K811587Siemens AngiotronSiemens Corp.IXOClass I
K811559Ventre/sep Ige Ria Test SetVentrex Laboratories, Inc.DGCClass II
K811556Dc-1 Cardiac Imaging ModuleDiasonics, Inc.DXKClass II
K811533Mgn Feeding TubeMgn Medical Manufacturing, Inc.KNTClass II
K811528Radiation BolusAction Products, Inc.JADClass II
K811503Epilator, Blend-Model Eb-200 & Et-1Rcx-Western, Inc.KCWClass I
K811501Epilator, Multiple Needle-Model Em-20Rcx-Western, Inc.KCWClass I
K811453Novatracer RecorderNovametrix Medical Systems, Inc.DSFClass I
K811421Hcg Radioimmunoassay Kit (125I)BD Becton Dickinson Vacutainer Systems PreanalyticJHIClass II
K811386Playtex Process Machinery ChangePlaytex, Inc.HILClass II
K811345InsightStaodynamics, Inc.GZJClass II
K811310Sodium/potassium Reagent KitsChem-Elec, Inc.CEMClass II
K811272Razel Model CRazel Scientific Instruments, Inc.FRNClass II
K811254Paper Chart RecorderAmerican Edwards LaboratoriesDSFClass I
K811253Cassette ReaderAmerican Edwards LaboratoriesDSHClass II
K811227Ct/t Datalink-B7875 Aa/b7875 AbGeneral Electric Co.JAKClass II
K811193Bun Rate ReagentChem-Elec, Inc.CDSClass II
K811069Fibrinogen Control PlasmaAmerican DadeKQJClass II
K810949MRI Prolactin Ria KitMicroanalytic Research, Inc.CFTClass I
K810871Lightning DialyzerClintox Laboratories, Inc.DHYClass I
K811424Electronic Apgar TimerPt&ELHBClass I
K811789Oeco Nasal CannulaOecoCATClass I
K811777Helena Plasminogen Quiplate ProcedureHelena Laboratories, Corp.DDXClass I
K811736Dcls AgarNeogen Culture MediaJSJClass I
K811735Cta MediumNeogen Culture MediaJSGClass I
K811734Brucella BrothNeogen Culture MediaJSGClass I
K811733Azide Blood Agar BaseNeogen Culture MediaJSJClass I
K811732Thiotone PeptoneNeogen Culture MediaJSKClass I
K811731Dextrose BrothNeogen Culture MediaJSGClass I
K811730BiosateNeogen Culture MediaJSKClass I
K811729ColumbiaNeogen Culture MediaJSGClass I
K811697GuamstainerTomtecKPAClass I
K811688Tungsten Syringe ShieldMedi-Physics Inc. dba Nycomed Amersham ImagingIWRClass I
K811684American Aircare SystemAmerican HamiltonFNMClass II