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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 3460 of 3526
510(k) clearances, page 3460 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K772016RespitraceRespitrace Corp.BZKClass II
K771933Cilco Anterior Chamber LensCalifornia Intraocular LensHQLClass III
K780082Peritoneal Dialysis Admin. SetPhysio Control, Inc.KDJClass II
K780076Epilator, Electronic Model Se-2R. A. Fischer Co. Corp.KCWClass I
K780061Pulse Generators, Models 5972/5973Medtronic, Inc.DXYClass III
K780045Electrode CapElectro-Cap Intl., Inc.GXYClass II
K780036Towel, Drape, BoundaryProcter & Gamble Mfg. Co.KKXClass II
K772369Needles Used in Angiographic Proced.Argon Medical Corp.DRCClass II
K772356Ldh Isoenzyme Column Reagent SetWorthington Biochemical Corp.CEXClass II
K772236Filter, Peritoneal Dialy. Admin. SetEMD Millipore CorporationKDJClass II
K772173Stethoscope, ElectronicAffiliated Mailorder Co. Sales, Inc.DQDClass II
K772085Las-R Human Plasminogen TestHyland Therapeutic Div., Travenol LaboratoriesDDXClass I
K772084Las-R Human C3 Proactivator TestHyland Therapeutic Div., Travenol LaboratoriesJZHClass II
K771981Minimap Model 810Applied Medical ResearchDSKClass II
K780067Hearing Aid, Behind-the-EarMaico Hearing Instruments, Inc.ESDClass I
K780063RubenosticonOrganon LLCGOKClass II
K780052Prosthesis, Double CupDepuy, Inc.JDIClass II
K780048Aminoglycoside Test SystemNichols Institute DiagnosticsDIDClass II
K780038Dental HandpieceLares Manufacturing Co., Inc.EFBClass I
K780031Fluorescence Detector Model 420Waters Assoc., Inc.KHOClass I
K780022Culture Media/isola. Patho. NeisseriaDiagnostic Culture SystemJTYClass II
K780012Antithrombin III RiaRia DiagnosticsDDQClass II
K780010Goat Anti-Rubella AntiseraNortheast Biomedical Labs., Inc.GOKClass II
K780009Guinea Pig Whole SerumNortheast Biomedical Labs., Inc.KISClass I
K780008Goat Anti-Influenza AntiseraNortheast Biomedical Labs., Inc.GQTClass I
K780007Goat Anti-Influenza AntiseraNortheast Biomedical Labs., Inc.GQQClass I
K780006Goat Anti-Influenza AntiseraNortheast Biomedical Labs., Inc.GNSClass I
K780005Goat Anti-Influenza AntiseraNortheast Biomedical Labs., Inc.GNSClass I
K780004Goat Anti-Influenza AntiseraNortheast Biomedical Labs., Inc.GNSClass I
K780003Endosolv ESeptodontKJJUnclassified
K772388Converse-Gillies Needle HolderEdward Weck, Inc.HXKClass I
K772266Instrument TrayMed Fusion Systems, Inc.FSMClass I
K772244Illuminated Dental HandpieceLitton Dental ProductsEFBClass I
K772219Fiax Test for Anti-Rubella AntibodyIdt, A Division of Whittaker M.A. BioproductsDHNClass II
K771953Gastrin Ria ModuleInter Science InstituteCGCClass I
K771948Glucagon Ria ModuleInter Science InstituteJMEClass I
K771947Insulin Ria ModuleInter Science InstituteCFPClass I
K780053Brace, Tennis ElbowBD Becton Dickinson Vacutainer Systems PreanalyticIQIClass I
K780032Urinary Leg BagC.R. Bard IncFAQClass I
K780028Orthodontic. Plastic Bracket Primer3M CompanyDYHClass II
K780001Epidural Lead - Model 3481Medtronic, Inc.GZBClass II
K772399Dingman Zygoma ElevatorEdward Weck, Inc.KADClass I
K772398Cottle Lower Lateral ForcepsEdward Weck, Inc.KAEClass I
K772397Cottle Columella ForcepEdward Weck, Inc.KAEClass I
K772396Alligator Cup ForcepsEdward Weck, Inc.KAEClass I
K772392Allport Mastoid RetractorsEdward Weck, Inc.KALClass I
K772391Boies Nasal Fracture ElevatorEdward Weck, Inc.KADClass I
K772390Day Ear HookEdward Weck, Inc.JYLClass I
K772385Thin-Bladed Nasal SpeculumEdward Weck, Inc.EPYClass I
K772384Myringotomy KnifeEdward Weck, Inc.JYOClass I