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 3092 of 3528
510(k) clearances, page 3092 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840512Streptococcus Pneumoniae ControlScientific Device Laboratory, Inc.GTYClass I
K840511Streptococcus Gr. DScientific Device Laboratory, Inc.GTYClass I
K840510Neisseria Meningitidis Gr. aScientific Device Laboratory, Inc.LSCClass I
K840509Neisseria Meningitidis Gr. BScientific Device Laboratory, Inc.LSCClass I
K840508Neisseria Meningitidis Gr. CScientific Device Laboratory, Inc.JTOClass I
K840507Neisseria Meningitidis Gr. YScientific Device Laboratory, Inc.LSCClass I
K840505Sdl Neisseria Menningitidis Gr. XScientific Device Laboratory, Inc.LSCClass I
K840504Sdl Neisseria Meningitides Gr. 2Scientific Device Laboratory, Inc.LSCClass I
K840503Sdl Listeria Monocytogenes ControlScientific Device Laboratory, Inc.GSIClass I
K840461Magic 125I Digoxin RadioimmunoassayCorning Medical & ScientificDONClass II
K840454Phototherapy Unit 7850 Neonatal PhotoAir-Shields, Inc.LBIClass II
K840449Amicon Diafilter 40. HemofilterMedical Device Consultants, Inc.KDIClass II
K840423Harrington-Type Instru-ScoliosisLink America, Inc.KWPClass II
K840416HexceliteHexcel MedicalITGClass I
K840400Emit St Serum Ethyl Alcohol AssaySyva Co.DMLClass II
K840340Chem-Stat AnalyzerOcean Scientific, Inc.JJQClass I
K840300Flush Solution Concentrate-Blood GasBionostics, Inc.CHLClass II
K840299Ph Electrode Calibrating Buffers-BloodBionostics, Inc.JISClass II
K840278Hdl Cholesterol Controls-LevelsPreventive Diagnostics Corp.JIXClass II
K840243Determin. of Salicylate in Serum/plastSigma Chemical Co.DKJClass II
K840230Fsh Quik Ria KitPacific Biotech, Inc.CGJClass I
K840227Urolix-3 Urological TableMedicor USA, Ltd.IXRClass II
K840220Hdl Cholesterol Aqueous StandardsPreventive Diagnostics Corp.JISClass II
K840219Triglyceride/cholesterol AqueousPreventive Diagnostics Corp.JIXClass II
K840218Triglyceride Aqueous StandardsPreventive Diagnostics Corp.JITClass II
K840217Cholesterol Aqueous StandardPreventive Diagnostics Corp.JISClass II
K840193Emit Qst Amikacin AssaySyva Co.KLQClass II
K840189Total Cholesterol Reagent SetPreventive Diagnostics Corp.CHHClass I
K840188Micromedic Lh & Fsh Ria KitMicromedic SystemsCEPClass I
K840187Immophase Dtesto Radioimmunoassay-Corning Medical & ScientificCDZClass I
K840156Protecta Coat SpongesAlimed, LLCIZZClass II
K840135CrisaX-Ray Tube Corp.ITYClass I
K840129Uni-Fast Analyzer SystemSclavo, Inc.JJEClass I
K840120AdvantageGilfordJJEClass I
K840051Coat-a-Count Estradiol KitSiemens Healthcare Diagnostics Inc.CHPClass I
K840018Dpc Acth KitSiemens Healthcare Diagnostics Inc.CKGClass II
K840006Kinetic Ldh, a< Blue 610 MethodAmerican Monitor Corp.CFJClass II
K834447Echo Mm1000Mesa Medical, Inc.LIFClass II
K834256Pbc Syringe IrrigatingPhiladelphia Biologics CenterFMFClass II
K834208Colloid Osmometer 4400ELITechGroup IncJJMClass I
K834115Cultrol-Antibiotic/antimycotic SolutBartels Immunodiagnostic Supplies, Inc.JSKClass I
K834113Tissue Culture Refeeding MediumBartels Immunodiagnostic Supplies, Inc.KITClass I
K834070Immpulse SystemParagon Diagnostics, Inc.JZTClass I
K834064Ortho Bi-Level Receptor ControlOrtho Diagnostic Systems, Inc.JJYClass I
K833957Erythropoietin EiaJcl Clinical Research Corp.GGTClass II
K833933Ace Color TestHana Biologics, Inc.KQNClass II
K832763Tobramycin ReagentBiosan Laboratories, Inc.KLBClass II
K840936Needle Catheter Jejunostomy Repair KitBiosearch Medical Products, Inc.KNTClass II
K840704Secure W/35mm Diam, Sheath/adhesiveWarne Surgical Products, Ltd.KNXClass II
K840703Secure W/30mm Diam, Sheath & AdhesiveWarne Surgical Products, Ltd.KNXClass II