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 3493 of 3526
510(k) clearances, page 3493 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770618Audiometer, Ma31Maico Hearing Instruments, Inc.EWOClass II
K770616Audiometer, Ma29, Pure Tone Air Conduct.Maico Hearing Instruments, Inc.EWOClass II
K770612Splint, BohlerWill Ross Co.IQIClass I
K770611Parallel BarsWill Ross Co.IOEClass I
K770610Table, Treatment & Traction, Hi-LoWill Ross Co.ITHClass II
K770609Table, Massage & Treatmhnt, Fixed HeightWill Ross Co.INTClass I
K770608Walking AidWill Ross Co.ITJClass I
K770607Traction HarnessWill Ross Co.ILZClass I
K770600Oropharyngeal Suction AirwayW.H. Wall, D.D.S.EBRClass I
K770526Digital ScannerRevvity Health Sciences, Inc.JXRClass I
K770464Toothbrush, Plak-a-DentSmith, Ranscht, Pollock, Manos & ConnorEFWClass I
K770444Spectrophotometer Analysis Sys., Aa-375Varian Assoc., Inc.JXRClass I
K770443Spectrophotometer Analysis Sys., Aa-175Varian Assoc., Inc.JXRClass I
K770385Latelet Determin. Kit, Cat No. 2521BD Becton Dickinson Vacutainer Systems PreanalyticGKLClass II
K770384Mnitrol Hemotol. Ref. and ControlBD Becton Dickinson Vacutainer Systems PreanalyticJPKClass II
K770363Aca Ammonia Analytical Test PackE.I. Dupont de Nemours & Co., Inc.JIFClass I
K770359Implanting of Polyacrylic FibersAllan V. MarseGBIClass I
K770352Meter, IV Ph, Model ExpandomaticBeckman Instruments, Inc.JQYClass I
K770622Conductivity Gel W/potassium ChlorideGraphic Controls Corp.GYBClass II
K770619Exercisor, RespiratoryCutter Laboratories, Inc.BWFClass II
K770617Audiometer, Ma30, Air & Bone ConductionMaico Hearing Instruments, Inc.EWOClass II
K7706151304A X-Y Display IntroductionHewlett-Packard Co.
K770614Monitor, Gas ManifoldDynatech Cryomedical Co.BXHClass I
K770514Sterilizer WrapC.R. Bard IncFRGClass II
K770507Pulse Generator, Litkicron Model 3-70HMedcor, Inc.DXYClass III
K770415Humidifier, DisposableM.G. Humidifiers, Inc.BTTClass II
K761225Low Level Human Albumin Test KitsIntl. Diagnostic TechnologyDCFClass II
K761224Ultra Low Level Immunoglobulin GIntl. Diagnostic TechnologyDEWClass II
K770621Stockinette, SurgicalThe Torrent Corp.KKXClass II
K770604Ria-Dac Tm Htsh KihMallinckrodt Critical CareJLWClass II
K770480In Vitro T-3 Uptake TestClinical Assays, Inc.KHQClass II
K770436Exerciser, Extensor WandMaddak, Inc.IONClass I
K770398MiniconAmicon, Inc.JJHClass I
K761009Lymphocyte Typing, Positive ControlHyland Therapeutic Div., Travenol LaboratoriesLGOClass I
K761008Lymphocyte Typing, Negative ControlHyland Therapeutic Div., Travenol LaboratoriesLGOClass I
K770599Nuva-Lite II Photo-Cure UnitDentsply Intl.EBZClass II
K770598Endodontic Instruments, R&r CutwellRansom & Randolph. LLC.EKPClass I
K770587Ventilator Adaptor, #751Surgicot, Inc.BZAClass I
K770586Universal Mouthpiece, #750Surgicot, Inc.BYPClass I
K770585Aerosol T Adapter, #752Surgicot, Inc.BZAClass I
K770574Cronex Quanta III Intensifying ScreensE.I. Dupont de Nemours & Co., Inc.EAMClass I
K770569Catheter, Embolectomy, UmiUniversal Medical Instrument Corp.DXEClass II
K770560Barrier O.b. Pack IVSurgikos, Inc.KKXClass II
K770558IsodyneHmw IndustriesECOClass I
K770532Pc-30 Pulmonary ComputerCavitron Corp.BZCClass II
K770531Unicam IUnion Carbide Corp.IYXClass I
K770530Cleon ImagerUnion Carbide Corp.JAMClass I
K770529Unicet IUnion Carbide Corp.IPSClass I
K770515Dispenser, Technetium, ClintichemUnion Carbide Corp.KPTClass II
K770509Table, Massage and TreatmentWill Ross Co.INTClass I