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 3158 of 3528
510(k) clearances, page 3158 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K831239Walrus Percutaneous Introducer SetMedical Parameters, Inc.DOYClass II
K831210Gentamicin Test Pack-AcaE.I. Dupont de Nemours & Co., Inc.DJBClass II
K831202Serum Uibc-Ptf-600 MethodAmerican Monitor Corp.JMOClass I
K831201Serum Iron-Ptf-600American Monitor Corp.JIYClass I
K831171DigicathArgon Medical Corp.DQOClass II
K831122William Harvey H-1700 Adult Blood Oxyg-C.R. Bard IncDTZClass II
K831015Diagnostics Ph Electrode Cleaning SolutFisher Scientific Company L.L.C.CHLClass II
K830980Amerlex Free T-3 Ria KitAmersham Corp.CDPClass II
K830913Minitrop Aerosal, Prodomo Aerosal andMedlog GmbH Marketing ServicesBTTClass II
K830862Neds-01 & Epr-500Biotronik Sales, Inc.DXYClass III
K830784Walk N RollMeta-MorrisITJClass I
K830758Azlin Azlocilin Sodium-Diag. ReagentMiles Laboratories, Inc.JTTClass II
K830715Norelco Vibrating Board V900North American Philips Corp.IROClass I
K830639Hi Flex D-700 Modular Bubble Oxygena-Electromedics, Inc.DTZClass II
K830577Linear Pump #4370975Wright Linear Pump, Inc.JOWClass II
K830566Converter Unit for ECG Trace DisplayHoneywell, Inc.DPSClass II
K830546Dosimetric ReleaseAmerican Hospital SupplyKQTClass II
K830489Recorder DmiDiagnostic Medical InstrumentsDSHClass II
K830375First Aid Bags #1,2,3Akla, Inc.FROUnclassified
K830313Cfe Total Hip Femoral ComponentZimmer GmbHJDIClass II
K830312AspiratorMarquest Medical Products, Inc.CBTClass I
K830311Auto StikMarquest Medical Products, Inc.CBTClass I
K830310OmnistickMarquest Medical Products, Inc.CBTClass I
K830173Bera Sh 221 Brian Stem AudiometerJEDMED Instrument CompanyGNJClass I
K823904Model 515 Neo-Trak Neonatal MonitorGE Medical Systems Information Technologies, Inc.DRTClass II
K823804Mycoplasmelisa Test KitM.A. BioproductsLJZClass I
K837430Auto D OptionTechnicare Corp.
K837378Omnimedical Quad II Digital Angiograph SystemOmnimedical
K837342Sharplan 721 CO2 Surgical LaserLaser Industries, Ltd.
K837230Model Nd1100 Bone Density ScannerMolsgaard Medical
K831359Modified New York MediumGibco Laboratories Life Technologies, Inc.JTYClass II
K831317Biopsy AttachmentDiasonics, Inc.FCIClass II
K831252Tumistore Recorder 1311Life-Tech Intl., Inc.LILUnclassified
K831230Pulse LavageMicro-Aire Surgical Instruments, Inc.
K831138Curved Hemostat 5Almore Intl., Inc.HTDClass I
K831137Straight 5 HemostatAlmore Intl., Inc.HTDClass I
K831108Home Pregnancy Test KitOrtho-Clinical Diagnostics, Inc.LCXClass II
K831107Coat-a-Count Neonatal T4 Kit Ria KitSiemens Healthcare Diagnostics Inc.CDXClass II
K831051Home Pregnancy Test Kit Hpk #1Ortho-Clinical Diagnostics, Inc.LCXClass II
K831034Qualistick Arterial Blood SamplerRadiometer America, IncCBTClass I
K831007Connecting TubesMedovations, Inc.BTAClass II
K831005Wire & Steinman PinsKirschner Medical Corp.HTYClass II
K830984Oxygen CathetersMedovations, Inc.BZBClass I
K830876Prep-CheckGeneral DevicesKRCClass II
K830823Z View Meter Model 300Lintronics Industries, Inc.KRCClass II
K830795Cabinet for Multiple Function BlocksElectronics for Medicine, Inc.DRTClass II
K830794Argyle Maden Silicone Gastrostomy TubeSherwood Medical Co.KNTClass II
K830786Disimetric Release of Instranetics RadAmerican Convertors Div., American PharmasealKOAClass I
K830687Norelco Electronic Analog Blood PressNorth American Philips Corp.DXNClass II
K830686Aneroid Blood Pressure Cuff #Hc1400North American Philips Corp.DXNClass II