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 3485 of 3526
510(k) clearances, page 3485 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K771040Introducer, Cat. #Int-07Fr.Sorensen ResearchDYBClass II
K770996Oxygen CannulaOhio Medical ProductsCATClass I
K770989Api 50 EAnalytical Products, Inc.JSEClass I
K770945Pouch, Tyvek-PolymylonMedical Disposables Intl., Inc.FPKClass II
K770912TiprotectorTower Products, Inc.KCTClass II
K770903Sterile Continer, X-Ray Cassette HolderNorth Shore Orthopaedic Group, S.C.IZLClass II
K770938Tinnitus Aid, Model S244Vicon Instrument Co.KLWClass II
K770826Pouch, Ileostomy, Odorproof, FeatherliteHowmedica Corp.FONClass I
K771109Orthopedic Soft GoodsMizuho Orthopedic Systems IncHSSClass I
K771078Phadebas T3 U TestPharmacia, Inc.KHQClass II
K771072Inserteo, Meta.-Phal.&thumb Carpo-MetaDepuy, Inc.HXOClass I
K771052Blood Collection Tube, LavenderSherwood Medical IndustriesGIMClass II
K771047Quanta-Mate Vitamin B-12/Folate RaBio-RadCDDClass II
K771038Thermometer, Single Use, Strip, TempadotOrganon LLCFQZClass I
K771037Thermometer, Single Use, Strip, TempadotInfo-ChemFQZClass I
K771031Stroke SlingStat Medical Corp.ILIClass I
K771030Flexion MittensStat Medical Corp.IODClass I
K770995Aerosol MaskOhio Medical ProductsBYGClass I
K770911Medishield Jordon Lifting FrameFraser Sweatman, Inc.FPPClass I
K770868Catheter, Polyurethane, W/styletAbbott MedicalDQOClass II
K770862Black Lamps,f72t12/bl/hoDermatron Corp.FTCClass II
K770802Markers, Stainless SteelCardio-Surgical, Inc.KPKClass II
K770671Calculator, Enzyme, TurnerTurner Assoc.JQPClass I
K770504Reagent SystemAmerican Monitor Corp.JGZClass II
K770228Aqueous Ph/blood Gas ControlsInstrumentation Laboratory Co.JJSClass I
K771104Urethral Tray W/out Cahteter, 7650Concord Laboratories, Inc.FCMClass II
K771103Urethral Tray W/catheter, 7750Concord Laboratories, Inc.FCMClass II
K771095J Hook HeadgearNorthwest Orthodontics, Inc.DZBClass II
K771082Deltascan 2000 SeriesOhio Nuclear, Inc.JAKClass II
K771081Litecast CeramicWilliams Gold Refining Co., Inc.EJHClass II
K771077Ultraviolet Rad-Emitting LampLee PharmaceuticalsEBZClass II
K771076Orthodontic Bracket AdhesiveLee PharmaceuticalsDYHClass II
K771069Multisonic (Super) Code TsmQualitoneESDClass I
K771065Dylade, Model DsMilton Roy Co. AnalyticalFKPClass II
K771064Ana TestGull Laboratories, Inc.DHNClass II
K771051C-Arm X-Ray SystemGeneral Electric Co.KPRClass II
K771023Analog Quantifier Model Aq-100Bio-Feedback Systems, Inc.HCCClass II
K771012Assure Deodorant TamponsPersonal Products Co.HILClass II
K770969Clev-Dent Colhs Electrosurg, Molel Tr-5Cavitron Corp.GEIClass II
K770964Goat Antiserum Complement C3 Nephel.Kallestad Laboratories, Inc.DAKClass II
K770963Goat Antiserum Igm NephelomhtricKallestad Laboratories, Inc.DFTClass II
K770962Goat Antiserum Iga NephelometricKallestad Laboratories, Inc.CZPClass II
K770961Goat Antiserum Igg NephelometricKallestad Laboratories, Inc.DEWClass II
K770920Thoracic Drainage Set, Argyle DualSherwood Medical IndustriesGAZClass II
K770864Hemodialysis Fistula SetVenospital, Inc.FIEClass II
K770765Reagent Set, RenorpaceG.D. Searle and Co.DPAClass I
K770743Soluset for IV Fat EmulsionAbbott MedicalFPAClass II
K770733Reagent System, Thyroxine, AriaBD Becton Dickinson Vacutainer Systems PreanalyticCDXClass II
K770731Eagent System, Cortisol, AriaBD Becton Dickinson Vacutainer Systems Preanalytic
K770704Gloves, Surgeons, LatexTillotson Rubber Co., Inc.KGOClass I