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 3159 of 3528
510(k) clearances, page 3159 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K830685Norelco Deluxe Digital Blood PressureNorth American Philips Corp.DXNClass II
K830684Norelco Electronic Digital Blood PressNorth American Philips Corp.DXNClass II
K830674Mahurkar Femoral CatheterQuinton, Inc.LFKClass II
K830592Dispos. Type T Thermocouple Temp.probeElectromedics, Inc.FLLClass II
K830525Api 20GpAnalytical Products, Inc.JSEClass I
K830254Life LineKb & Assoc.DXHClass II
K831177Stratus Digoxin Fluorometric Enzyme Imm-American DadeKXTClass II
K831363Testcorp AsoCatheter Technology Corp.GTQClass I
K831349Streptococus Id PlateGranite Diagnostics, Inc.JSTClass I
K831335Disposable Base MoldSurgipath Medical Industries, Inc.KERClass I
K831310Brace c.t.Innovation Sports, Inc.ITQClass I
K831308Disposable Microtome BladeSurgipath Medical Industries, Inc.IDLClass I
K831247Safe-Seat Wheelchair CushionD.A. Schulman, Inc.KICClass I
K831242Lithium Heparinized Blood Collect-TubeAmerican DadeJKAClass II
K831231LED GogglesCadwell Laboratories, Inc.HLXClass II
K831226Medical Products Foam Double Scrub #450Ballard Medical ProductsGECClass I
K831209Gentamicin Calibrator -AcaE.I. Dupont de Nemours & Co., Inc.DLJClass II
K831207Spunguard Scrub SuitKimberly-Clark CorporationFXOClass I
K831154Stratus Phenytoin Fluorometric EnzymeAmerican DadeLESClass II
K831146OxycoilChanning Corp.BYXClass I
K831105Cordia PapCordis US Corp.JFHClass II
K831093Apello, Personal Health Support Sys.Almicro Electronics, Inc.ILQClass II
K831081Ezee Filter/separatorThe Kendall Company Div. of Tyco Healthcare GroupJKAClass II
K831042Chemonucleolysis Table ExtensionMizuho Orthopedic Systems IncFSEClass I
K831027Extrelut Qe Extraction ColumnsEMD Millipore CorporationKEAClass I
K830902Ocucare PackOcular Innovations, Inc.HQCClass II
K830898Syringe 500Bc Be #7000Instrumentation Industries, IncorporatedBXWClass I
K830749Platelet AggregometerChrono-Log Corp.JBXClass II
K830441Diff 4 SystemCoulter Electronics, Inc.EKZClass II
K830209Lus Acetabular ComponentZimmer GmbHJDIClass II
K831279Clostridium Difficle MediaGibco Laboratories Life Technologies, Inc.JSJClass I
K831268Till-U-Test G.c. Gonococus SlidePasco Laboratories, Inc.JTYClass II
K831219Clostridium Difficile Selective SuppleGibco Laboratories Life Technologies, Inc.JSKClass I
K831047Biologic System Bl 101Bio-Logic Systems Corp.GWEClass II
K830978Helena Biostrip aHelena Laboratories, Corp.JMAClass I
K830925Mf 380 Electrosurgical UnitZimmer GmbHGEIClass II
K830873S & W Model AsoS & W Enterprises, Inc.KNCClass II
K830825Yield Non-Adherent DressingProfessional Medical Products, Inc.FROUnclassified
K830701Stratus Phenobarbital Fluorometric EnzAmerican DadeLETClass II
K830563Cortisol Radioimmunoassay Kit-CortctkSorin Biomedica, Fiat, USA, Inc.CGRClass II
K830507Sysmex Cc-170Toa Medical Electronics USA, Inc.GKLClass II
K830374Rescue PackAkla, Inc.KDDClass I
K830373First Aid KitAkla, Inc.FROUnclassified
K830045Mumpselisa Test KitM.A. BioproductsLJYClass I
K837344Beam Block ShaperMick Radio-Nuclear Instruments, Inc.
K837331Corneomap 4500 Ultrasound MeasurementRadionics Medical, Inc.
K837304Models 246 and 210F Linear Array Ultrasound ScannerAloka Co., Ltd.
K837085Doppler for Detecting Occlusions and Taking Systolic Blood PressureE.M. Adams Co., Inc.
K831265Dentolock Denture Adhesive CreamSolar Dental Co., Inc.KOQClass I
K831259Reservoir 1.5Cc #9210 W/25 Gauge/needleCardiac Pacemakers, Inc.FRNClass II