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 3076 of 3528
510(k) clearances, page 3076 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K841189Oec/rezaian Spinal FixatorOrthopedic Equipment Co., Inc.KWQClass II
K841101Clayman-Parel Capsule CoupeurMiami Eye Technology, Inc.HNYClass I
K841087Flexible Orthopedic Endoscope Ica-1000Machida America, Inc.HRXClass II
K841075Carciac Pulse Generator 254-20Intermedics, Inc.DXYClass III
K841074Cardiac Pulse Generator 254-18Intermedics, Inc.DXYClass III
K841073Quantum, Unipolar, Multi-ProgrammableIntermedics, Inc.DXYClass III
K840906Hearing Aid Audio-Starr aJade Electronics Corp.ESDClass I
K840883Unipak 100 Analyzer, 65156 & ChemistrEMD Millipore CorporationJJEClass I
K840737Implantable Programmable Pulse GenerTelectronics, Inc.DXYClass III
K840121Physiological Pressure Transducer 1290CHewlett-Packard Co.DRSClass II
K833632Aries Medical Model 700Aries Medical, Inc.DSPClass II
K841849Isostation Shoulder MachineIsotechnologies, Inc.IKKClass II
K841836Selective Culture Med. TrichomonasMicroline ScientificJSDClass I
K841835Multipurpose Culture MediumMicroline ScientificJSGClass I
K841834Culture Medium for Antimicrobial SuscepMicroline ScientificJTZClass II
K841833Culture Medium for Pathogenic NeisserMicroline ScientificJTYClass II
K841830Ultra-Lite PremierEverest & Jennings, Inc.IORClass I
K841755Mueller-Hinton AgarThe Montana Deaconess Medical CenterJTZClass II
K841722Mass Spectrometer InterfaceDryden Corp.BZOClass I
K841660Selenite Cystine Broth BaseOxoid U.S.A., Inc.
K841584Medtronic Resume Se-4 3587-Lead-SpinalMedtronic, Inc.GZBClass II
K841553H-H Shunt PassersHolter-Hausner Intl.GYKClass I
K841498C02 Monitor-Oir-7101Nihon Kohden America IncCCKClass II
K841477Corometrics 815 Fetal ECG RecorderGE Medical Systems Information Technologies, Inc.HGMClass II
K841373Provider IV Model 2000 Infusin SysPancretec, Inc.FRNClass II
K841307Bbl Gaspak PouchBD Becton Dickinson Vacutainer Systems PreanalyticFKJClass II
K841195Glas Ionomer CementShofu Dental Corp.EMAClass II
K841106Delta Multiple Non Return ConnectorTefra Med, Inc.FPAClass II
K840966Anesthetic Gas Monitor SysMarquest Medical Products, Inc.CCKClass II
K840929Frc 85 Series SpirometerMedical Equipment Designs, Inc.BZGClass II
K840908Chestac-25F SpirometerMedical Equipment Designs, Inc.BZGClass II
K840828Kyotest 8VKyoto Diagnostics, Inc.JMTClass I
K840827Kyotest 5VKyoto Diagnostics, Inc.CENClass I
K840735Femoral Cement Removal InstrumentAmtech Scientific, Inc.HWXClass I
K840431Scratch & Sniff for AnesthesiaDryden Corp.CAIClass I
K834387Yd Strip Gph U21Yd Pharmaceutical Corp.JILClass II
K834386Yd Strip Gp U20Yd Pharmaceutical Corp.JILClass II
K834270Ortho Enzyme Immunoassay Home Preg.testAdvanced Care ProductsLCXClass II
K833799Sphygomano MeterFraser Harlake, Inc.DXNClass II
K841745Hektoen Enteric AgarThe Montana Deaconess Medical CenterJSIClass I
K841744Dulbecco's Phosphate Buffered SalineSigma Chemical Co.KITClass I
K841700Walk & RollMaddak, Inc.INMClass I
K841661Synthetic Broth A.o.a.c.Oxoid U.S.A., Inc.JSTClass I
K841658Kf Streptococcus AgarOxoid U.S.A., Inc.JSJClass I
K841582Optimate Digoxin TestMiles Laboratories, Inc.KXTClass II
K841542Omnidirectional Powered Wheel ChairKCI USA, Inc.ITIClass II
K841533Aca Tricyclic Antidepressants ScreenE.I. Dupont de Nemours & Co., Inc.LASClass I
K841516Ventrescreen, Multiple Allergen DiscsVentrex Laboratories, Inc.DHBClass II
K841422Volume Test Dye 6Reagent Laboratory, Inc.JJOClass I
K841421Daily Wash Solution 5Reagent Laboratory, Inc.JJOClass I