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 3191 of 3528
510(k) clearances, page 3191 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K823434Mikro-Tip Catheter Pressure TransducerMillar LLC.DRFClass II
K823433Balloon Thermodilution Catheter #7164&Critikon Company, LLCDYGClass II
K8234321512M/f Wire Electrode Needle SetLife-Tech Intl., Inc.FAPClass II
K823346Accuset Administration SetImed Corp.FPAClass II
K823312Cadio-Respiratory Monitor #Cr-2Electromed Intl., Ltd.DRTClass II
K823217Inpersol Peritoneal Dialsis Cycler SetAbbott MedicalFKXClass II
K823204Betatron IICardiac Pacemakers, Inc.FRNClass II
K823193Ambulatory Insulin Infusion Pump 9205Cpi, Inc.FRNClass II
K823108Intersept Pediactric Extracorporeal FiltExtracorporeal Medical Specialities, Inc.DTMClass II
K823063Flo-Gard 2000 Enternal Pump & TravasorbTravenol Laboratories, S.A.FRNClass II
K823052The 500 Monitor SeriesVitatekDXNClass II
K822964Right Atrial CatheterQuinton, Inc.LFJClass II
K822781Medtronic Models 4011 & 4511Medtronic, Inc.DTBClass III
K823400Arthroscopic Leg HolderMizuho Orthopedic Systems Inc
K823399Cover LimbMizuho Orthopedic Systems IncIPMClass I
K823397Anatomic Fracture BraceMizuho Orthopedic Systems IncITQClass I
K823396Free Flex Heel Height AdjustorMizuho Orthopedic Systems IncISHClass I
K823392Forearm Reduction UnitMizuho Orthopedic Systems IncHSTClass I
K823391Leg Prep HolderMizuho Orthopedic Systems Inc
K823366Hearing Aid Ue-10-HUnitron Industries, Inc.ESDClass I
K823285Model Who1 Hearing AidPanasonic Co. Div. Matsu Elec. Corp. AmericaESDClass I
K823237Barbiturate Test Set #0550-050Stanbio LaboratoryDJNClass II
K823233Sba 300 Clinical Chemistry AnalyzerGilford Instrument Laboratories, Inc.JJCClass I
K823212Abuscreen Radioimmunoassay - AmphetamineHoffmann-La Roche, Inc.DJPClass II
K823201Human Placental Lactogen KitSiemens Healthcare Diagnostics Inc.JMFClass II
K823200125 I-Dehydroepiandrosterone SulfateWien Laboratories, Inc.JKCClass I
K823199Enzyme-Test DigoxinIcl ScientificKXTClass II
K823196Special Control Serum for Hdl-CholesBoehringer Mannheim Corp.JJKClass I
K823170Liquizyme Total Protein ReagentAmresco, Inc.CEKClass II
K823144Single Step Free-T4 125I Radioimmuno-Corning Medical & ScientificCECClass II
K823143Bubble HumidifiersSeven Harvest Intl. Import & ExportBTTClass II
K823142Oxygen TubingsSeven Harvest Intl. Import & ExportBYXClass I
K823141Oxygen MasksSeven Harvest Intl. Import & ExportBYGClass I
K823138Cell ScraperCorning Costar Corp.KJAClass I
K823129Advance Emit-Cad N-AcetylprocainamideSyva Co.LANClass II
K823128Advance Emit Cad Procainamide AssaySyva Co.LARClass II
K823127Advance Emit-Cad Procainamide/n-AcetylSyva Co.LAZClass I
K823112Clinistat Tda SeriesMiles Laboratories, Inc.KHOClass I
K822910Right Arterial CatheterQuinton, Inc.LFJClass II
K822849Raaf Dual Lumen CatheterQuinton, Inc.
K822785Fluoroset Immunofluorescent AntibodyImmulok, Inc.GQLClass II
K823132Sartophor System for ElectrophoresisSartorius Filters, Inc.JJNClass I
K823398Lateral PositionerMizuho Orthopedic Systems Inc
K823347Macrodot Add-I-Med Admin. SetImed Corp.FPAClass II
K823326Dental Instruments - Cutting InstrumentMiltex, Inc.ELAClass I
K823325Dental Instruments - Surgical ForcepsMiltex, Inc.EMGClass I
K823324Dental Instruments - ProbesMiltex, Inc.EIXClass I
K823323Dental Instruments - Plastic InstrumentsMiltex, Inc.EIYClass I
K823322Dental Instruments - PluggersMiltex, Inc.EKGClass I
K823321Dental Instruments - CarverMiltex, Inc.EKHClass I