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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
46,132 of the 176,529 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
20262,732
176,529 records, page 2217 of 3531
510(k) clearances, page 2217 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K940601Gambro Bicart 720GC.G.H. Medical, Inc.KPOClass II
K940575Aspir-Pulse(tm) Saf-T-VentSherwood Medical Co.CBTClass I
K9405583M Xp-2000 X-Ray Film Processor3M CompanyIXWClass II
K940478Ecat PrtSiemens Medical Solutions USA, Inc.KPSClass II
K940379ExtrudeSybron Dental Specialties, Inc.ELWClass II
K940313Phonic EarPhonic Ear, Inc.EPFClass II
K940110M-K Wet Saline DressingMason-Keller Corp.FROUnclassified
K940089Cbc-Cobas 5 Hematology Control/multipleR & D Systems, Inc.JPKClass II
K936204Glycated Hemoglobin CalibratorsTrinity Biotech (Primus Corporation dba Trinity Biotech)LCPClass II
K936194Coaxial Biopsy NeedleBard Gynecology and RadiologyFCGClass II
K936030Cedia Dau Barbiturate AssayMicrogenics CorporationDISClass II
K936019Nomos Stereotactic Biopsy InstrumentsNomos Corp.HAWClass II
K936012Therex Low Profile Port-Titanium ModelTherex Corp.LJTClass II
K935867Air Conduction Hearing Aid, Unitron Ikon K & KdUnitron Industries, Inc.ESDClass I
K935819Quality Control Material (Assayed)Columbia Diagnostics, Inc.DKCClass I
K935816Vidas T UptakeBiomerieux Vitek, Inc.KHQClass II
K935606Serum Ammonia ControlP.T. MeditrolJJXClass I
K935543Aca Plus Ferritin CalibratorE.I. Dupont de Nemours & Co., Inc.JIXClass II
K935529Cervical Self-Retaining RetractorT. Korossurgical Instruments Corp.GZTClass II
K935488Alatop(r) Microplate Allergy ScreenSiemens Healthcare Diagnostics Inc.DHBClass II
K935469Synelisa Dhea-SulfateElias U.S.A., Inc.JKCClass I
K935285Drugs of Abuse ControlsMedical Diagnostic Technologies, Inc.DIFClass I
K935219Fertility Plus 1, 2, 3Ciba Corning Diagnostics Corp.JJYClass I
K934962Aim Supracondylar NailAce Orthopedic Manufacturing Co.HSBClass II
K934802Therex Low-Profile Port-TitaniumTherex Corp.LJTClass II
K934792Therex Low-Profile PortTherex Corp.LJTClass II
K934764Vidas T3 AssayBiomerieux Vitek, Inc.CDPClass II
K934643Ace Humeral NailAce Orthopedic Manufacturing Co.HSBClass II
K934506Dynabite Hysteroscopic ForcepsPortlyn Corp.HETClass II
K933972N-Assay Tia IggCrestat Diagnostics, Inc.CFFClass II
K933971N-Assay Tia IgaCrestat Diagnostics, Inc.CFNClass II
K933970N-Assay Tia IgmCrestat Diagnostics, Inc.CFNClass II
K933804Lectron II Conductive Gel/cadwell Electrode GelCadwell Laboratories, Inc.GYBClass II
K933277Coagulation A.r.p.Helena Laboratories, Corp.GGNClass II
K932848Simulix-Mc CT ExtensionOldelft Corp. of AmericaJAKClass II
K932460Acufex Meniscal RaspsAcufex Microsurgical, Inc.HRXClass II
K932407Cadwell Easy Writer and Easy ReaderCadwell Laboratories, Inc.GWQClass II
K930267Biomerieux Uniplasmatrol Normal & AbnormalBiomerieux Vitek, Inc.GGCClass II
K926287Exercise BicycleHenley Intl.ISDClass II
K926280Standard Nebulizer HeaterProfessional Medical Products, Inc.CAFClass II
K926216Bone Cement RestrictorBiodynamic Technologies, Inc.JDKClass II
K925236L Cath(r) Catheter SystemLuther Medical Products, Inc.LJSClass II
K924481Insufflation TubingApplied Medical Resources CorpHIFClass II
K922777Pressure Tubing and AccessoriesArbor Technologies, Inc.HIFClass II
K940719SilfreeArgen Precious Metals, Inc.EJTClass II
K940619Silfree 79+Argen Precious Metals, Inc.EJTClass II
K940618Aurolite 41Argen Precious Metals, Inc.EJTClass II
K940617Surefire 12Argen Precious Metals, Inc.EJTClass II
K940535Auto Lube SystemThe Anspach Effort, Inc.GEYClass I
K940458Miracle-Ear ConfidanteMiracle-Ear, Inc.ESDClass I