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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 3194 of 3528
510(k) clearances, page 3194 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823023Km-Kal L6Kmn Products, Inc.JITClass II
K823022Km-Kal 6Kmn Products, Inc.JITClass II
K823021Km - Kal 5Kmn Products, Inc.JITClass II
K823020Km-Kal 4Kmn Products, Inc.JITClass II
K823019Km-Kal 3Kmn Products, Inc.JITClass II
K823001Peptone Iron AgarGranite Diagnostics, Inc.JSFClass I
K823000Macate BrothGranite Diagnostics, Inc.JSFClass I
K822999Dnase Test Agar W/toluidine BlueGranite Diagnostics, Inc.JSFClass I
K822998Christensens Citrate Sulfide AgarGranite Diagnostics, Inc.JSEClass I
K822996Jordans Tartrate AgarGranite Diagnostics, Inc.JSFClass I
K822995Andrades Fermentation MediaGranite Diagnostics, Inc.JSFClass I
K822994Corn Meal Agar W/polysorbate 80Granite Diagnostics, Inc.JSJClass I
K822986Pulmonary Function Lab System 1070Medical Graphics Corp.BZCClass II
K822977Hemoglobin Alc by Column TestBio-RadLCPClass II
K822976Hypocount aPharmaquest Corp.CGAClass II
K822971Saliva SubstituteRoxane Laboratories, Inc.LFDUnclassified
K822962Microfluor B Removawell StripsDynatech Corp.LIBClass I
K822960Microfluor B Plate & Micro Fluor W PlateDynatech Corp.LIBClass I
K822954Microtech Bacterial ControlsUniversal Micro Reference LaboratoryJTRClass I
K822912Bear Vm-90 Ventilation MonitorBear Medical Systems, Inc.BZKClass II
K822888Ohio Cpu-1 Intensive Care VentilatorOhio Medical ProductsCBKClass II
K822879Enteral Nutrition 1Exco, Inc.KNTClass II
K822864Intracranial Pressure Monitoring DeviceMedex, Inc.GWMClass II
K822841The Emd Tenz Pain Control SystemElectro Medical DevelopmentGZJClass II
K822635225 S.i.m.v. VentilatorMonaghan Medical Corp.CBKClass II
K822327Calibrator for Hemoglobin & HemocritInterscience, Inc.KRZClass II
K822315Gfb-B Contact Lens BlanksHamel, Park, Mccabe & SaundersHPXUnclassified
K822946Bactec Nap Tb Differentiation TestBD Becton Dickinson Vacutainer Systems PreanalyticJTOClass I
K823166Pelvic Traction BeltWarm & Form, Orthopedic MaterialsILZClass I
K823163Universal Bucks TractionWarm & Form, Orthopedic MaterialsKQZClass I
K823162Universal Sling, Sling & SwatheWarm & Form, Orthopedic MaterialsILIClass I
K823161Cervical CollarWarm & Form, Orthopedic MaterialsIQKClass I
K823160Rotation BootWarm & Form, Orthopedic MaterialsIQIClass I
K823159Deluxe Knee ImmobilizerWarm & Form, Orthopedic MaterialsITQClass I
K823158Rib Belt (Universal)Warm & Form, Orthopedic MaterialsIPXClass I
K823157Clavicle SupportWarm & Form, Orthopedic MaterialsIQJClass I
K823109Generic Pregnancy TestDiagnostic SpecialtiesLCXClass II
K823100Rx 91Bauer, Cheng & Associates, Inc.EJSClass II
K823099Rx MidacastBauer, Cheng & Associates, Inc.EJTClass II
K823098Rex-CapsBauer, Cheng & Associates, Inc.EJJClass II
K823097NaturelleBauer, Cheng & Associates, Inc.EJSClass II
K823084ChallengerBauer, Cheng & Associates, Inc.EJSClass II
K823062Kenamycin Fluorescent Immunoassay FiaAmerican Diagnostic Corp.KJIClass II
K823053Nml-Tetra-Tube RiaNuclear Medical Laboratories, Inc.CDXClass II
K822984Id-Zone Ld Isoenzyme ControlBeckman Instruments, Inc.JJTClass I
K822341Allergenetics Ige-Fast TestAllergeneticsDGCClass II
K822272Head Mirrors W/head Lamps & Head BandsKelleher Corp.HPQClass II
K823120Exacta & Connecta Stopcocks W/extensionPioneer Viggo, Inc.FMGClass II
K823075RextonArgosy Intl. (USA), Inc.
K823074Chemdi Steam & Gas Sterilization IndicaAmerican Sterilizer Co.JOJClass II