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 3161 of 3528
510(k) clearances, page 3161 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830513First TmPhasealloyEBFClass II
K830508Sysmex Cc-180Toa Medical Electronics USA, Inc.GKLClass II
K830506Sysmex Cc-150Toa Medical Electronics USA, Inc.GKLClass II
K830505Sysmex Cc-130Toa Medical Electronics USA, Inc.GKLClass II
K830477Cardiomemo IIIInstromedix, Inc.DXHClass II
K830465Widex Hearing Aid #G2h & G2tWidex Hearing Aid Co., Inc.ESDClass I
K830439Denta a-33Denta, Inc.EGGClass I
K830425Toilet Seat RaisedMaddak, Inc.ILSClass I
K830259Protet Soap & Wash MittRitmed, Inc.GEDClass I
K830182Custom IV SetCustom Medical, Inc.FPAClass II
K830113SeptopackNorth Pacific Dental, Inc.EMAClass II
K823294Medigroup Ls-110 Light SourceMedigroupHETClass II
K822085Pro-ScopeExitec, Inc.FERClass II
K837382Optison Ultrasonic ScalerKaVo Dental Technologies, LLC
K823297St-610 Needlescope Sterilization TrayMedigroupHETClass II
K823295Medigroup 2.2Mm Needlescope Cannula&MedigroupHETClass II
K831125Btc Urine Lcg AssayBtc Diagnostics, Inc.JHJClass II
K831032Api AnaidentAnalytical Products, Inc.JSPClass I
K831016Bath ClearFisher Scientific Company L.L.C.CHLClass II
K831010Diagnostics Po2 Electrode CleanerFisher Scientific Company L.L.C.CHLClass II
K830979Helena Biostrip PhHelena Laboratories, Corp.CENClass I
K830837La-Histo Antibody System #Hl 1001IMMY, Inc.GMJClass II
K830803Urinary Diversion StentVan-Tec, Inc.LJEUnclassified
K830708Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & SonsFROUnclassified
K830580Diagnon Ferritin 125 I Ria KitIagnon Corp.DBFClass II
K823805Varicelisa Test KitM.A. BioproductsLFYClass II
K823293Medigroup Lg-102 Light GuideMedigroupHETClass II
K821135Prealbumin Enzyme ImmunoassayAbbott MedicalJZJClass I
K831100Medica Iif-Multiple Antibody Test KitMedical Diagnostics, Ca.DBMClass II
K830976Helena Biostrip KHelena Laboratories, Corp.JINClass I
K830975Plan a LifeNew Directions Co.JINClass I
K830964Anaerobe Mic/id Template, & TaxonomyBD Becton Dickinson Vacutainer Systems PreanalyticJSPClass I
K830962Immuchem Covalent-Coat Ria KitImmuchem Corp.DPOClass II
K830959Flow-Pac Sgpt ReagentAmresco, Inc.CKAClass I
K830958Flow-Pac Sgot ReagentAmresco, Inc.CITClass II
K830804Labile Removing Hemolyzing ReagentCorning Medical & ScientificJBDClass II
K830640Boo-Boo StripColossus Corp.FROUnclassified
K830342Culuture Set Chlamydia Isolation andImmulok, Inc.LKIClass I
K831165Dustcovers/sterility Maintenance CoversMedical Industries Packaging, Inc.KCTClass II
K831163Lo-Comp Reservoir-Re-1000Cygnus Research Corp.BTTClass II
K831149Personal Knee Crutch PadTecnol New Jersey Wound Care, Inc.INPClass I
K830993AmpligreffeProthia USA, Inc.GFDClass I
K830988Oxygen Connecting TubeMedovations, Inc.BYXClass I
K830923Temp-Check Adaptor, Straight ConfiguraCygnus Research Corp.BZOClass I
K837224UnknownXanar, Inc.
K830922Temp-Check Adaptor, Tee-ConfigurationCygnus Research Corp.BZOClass I
K830921Temp-Check Adaptor, Y-ConfigurationCygnus Research Corp.BZOClass I
K830859I/a KitSurgeon Surgical Instrumentation, Inc.GBXClass I
K830750Cemented 101 32 Femoral ComponentIntermedics OrthopedicsJDIClass II
K830735Bt 795/A AutotransElectromedics, Inc.CACClass II