510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3033 of 3529
510(k) clearances, page 3033 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K844044Lytetek 1000 Na/k Sodium/potassium AnalyzerMedica Corp.CEMClass II
K844036US 610Rich-Mar Corp.IMIClass II
K844033Mobilimb Hand UnitDanninger Medical Technology, Inc.JFAClass I
K844027Seracon Tm Sr IIIBhp Diagnostix, Inc.JIXClass II
K844026Seracon Tm Sr IVBhp Diagnostix, Inc.JIXClass II
K844018Gas Trak Brand Co-Oximeter Controls 1,2 & 3United Diagnostics, Inc.JJYClass I
K843986Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3United Diagnostics, Inc.JJYClass I
K843914Cobas Fluorescence Polarization ModuleRoche Diagnostic Systems, Inc.JJGClass I
K843897Pocket Ophthalmoscope GhDesign Med. Corp.HLJClass II
K843880Low Profile Steerable Balloon DilationAdvanced Cardiovascular Systems, Inc.LITClass II
K843877Ultima Chiropractic TablesElenex Medequip, Inc.INQClass I
K843859Lauf-Ergotest JuniorErich Jaeger, Inc.IOLClass I
K843855Ergotest 40 & 45Erich Jaeger, Inc.ISPClass I
K843853Lauf-ErgotestErich Jaeger, Inc.IOLClass I
K843850Universal-ErgotestErich Jaeger, Inc.ISDClass II
K843832Triglycerides Reagent SystemFermco Biochemics, Inc.CDTClass I
K843587Petit BandsMicori Gifts, Inc.KGXClass I
K843454Ultra Lyte Potassium Reagent KitUltra Quest Diagnostics, Inc.CEMClass II
K843453Ultra Lyte Sodium Reagent KitUltra Quest Diagnostics, Inc.JGSClass II
K843437Mei Mammography Sys Mx-2049Moti Enterprises, Inc.IZHClass II
K843413Stress Control Biofeedback CardPilgrim Plastic Products Co.HCCClass II
K843386Mendez u/s CystotomeCooperVision, Inc.HQCClass II
K843340Porta-StatPorta-Stat, Inc.IWYClass I
K843335Floor Mounted X-Ray TubestandMedicor USA, Ltd.IYBClass I
K843278Iocare Ultrasonic Titanium TipsChiron Vision Corp.HQCClass II
K843277Iocare Phacoemulsification PackChiron Vision Corp.HQCClass II
K843275Iocare Irrigation/aspiration PackChiron Vision Corp.HQCClass II
K842979Cavitron/kelman Phaco-Emulsifier AspiraCooperVision, Inc.HQCClass II
K842706ScataidSc Applied Technology, Inc.DXGClass II
K841545Enzyme Immunoassay for Detection HormBtc Diagnostics, Inc.CEPClass I
K841227Bipolar Endocardial Lead 406LSiemens Elema ABDTDClass II
K844318Oral Irrigation TipPro Pulse, Inc.EFSClass I
K844292Medi-Tech Dilatation CathetersMedi-Tech, Inc.LCNClass I
K844291Ark Tongue CleanerArkay Co.LCNClass I
K844224Eixo Thermus Heating PadsEixo ThermusIMDClass I
K844067Vanish Orthodontic BracketA Company, Inc.EJFClass I
K844060Isostation Ankle/subtalar Machine a-100Isotechnologies, Inc.IKKClass II
K843688Kareco Int'l WheelchairKareco Intl., Inc.IORClass I
K843638Health Pulse Fa-222 Power Muscle StimulTherapeutic Equipment Corp.IPFClass II
K843572Pdb II Vibrating Drainage BedInvacare GmbHJFBClass II
K843468Pharma-Plast Suction Set Type YankauerZimmar Consulting, Ltd.GEAClass I
K840566Bone Stapling Fixation Sys3M CompanyJDRClass II
K844323Konan Clinic Microscope Clm-100-150Keeler Instruments, Inc.HRMClass I
K844236PristineMedical DimensionsKGOClass I
K844129Shure Grip Tying ForcepsMentor O & O, Inc.HNRClass I
K844082Quest Beta Hcg Enzyme Immunoassay KitOrtho-Clinical Diagnostics, Inc.JHIClass II
K843992Cilcor Ophthalmic InstrumentsCilco, Inc.HNRClass I
K843366SuperpettScanditronix, Inc.KPSClass II
K843304Binocular Indirect OphthalmoscopeMentor O & O, Inc.HLIClass II
K843099Mamiya Slit Lamp P-1Okada Corp.HLIClass II