510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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 3123 of 3528
510(k) clearances, page 3123 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K833588Vascular Laboratory Treadmill Vt1Medasonics, Inc.IOLClass I
K833587Disposable Arthroscopy BladeDyonics, Inc.HRXClass II
K833515Bouins SolutionSigma Chemical Co.IGNClass I
K833510Panasonic Wh-50 Hearing AidPanasonic Co. Div. Matsu Elec. Corp. AmericaESDClass I
K833458Case-IIMarquette Electronics, Inc.DPSClass II
K833451Tel-Star Nuway & Generic E Asp-BpOmni Hearing SystemsESDClass I
K833335Modulus II Anesthesia Gas MachineOhio Medical ProductsBSZClass II
K833334Behind the Ear Asp-BbOmni Hearing SystemsESDClass I
K833331Aspiration & Irrigation CatheterMicrovasiveOCXClass II
K833330Muto BrushMicrovasiveFDXClass II
K833324Specific Atlas MicrojustHaygood Scientific Tool Co.
K833321Labor/delivery/recovery Bed Ldr-600Adel Medical, Ltd.KNCClass II
K833292Lactabacillus Agar W/o Tween80Neogen Culture Media
K833180Gonochek-IIE-Y Laboratories, Inc.JSXClass I
K833151Boyle System Anesthesia Gas MachineFraser Harlake, Inc.BSZClass II
K833138Digital Injector SysSybron Corp.DXTClass II
K833134Rionet Hearing Aid Hb-345Rion Acoustic Instruments, Inc.ESDClass I
K833072Technicon Ra-1000 Sys-Ise Module &Technicon Instruments Corp.JGSClass II
K833070Tdx TheophyllineAbbott MedicalLERClass II
K833055Laryngoscope Blades/handles & LampsMedovations, Inc.CCWClass I
K833053Y CeramicJeneric Ind.EJTClass II
K833052RxgJeneric Ind.EJTClass II
K833005Paramax Bilirubin CalibratorsAmerican DadeJIXClass II
K832992Soffban Orthopedic PaddingSmith & Nephew, Inc.ITGClass I
K832975Bacterueria Screening ProcedureTurner Designs, Inc.JXAClass I
K832959Pacemaker Sys. Analyzer 378Siemens Elema ABKREClass II
K832916Inivox Electrode/catheter SysCritikon Company, LLCLLEClass III
K832914Prima-Unipolar Cardiac Pulse GeneratIntermedics, Inc.DXYClass III
K832910Defazolin 30Mcg. Sensitivity DiscsDifco Laboratories, Inc.JTNClass II
K832900Immunoenzyme Test Sys-Detect-Igm AntiBionetic Laboratory ProductsGLZClass II
K832859Foam Helmet - Use W/esophageal TamponaInmed Corp.KNTClass II
K832700Pneu Pac Ventilator/resuscitatorsPneupac, Ltd.CBKClass II
K832691Beta Scan Reagent StripOrange Medical Instruments, Inc.CGAClass II
K832605Trancoject Disposable SyringesHuborga, Inc.FMFClass II
K832393Encodyne 4 & Vacufix 4Elmed, Inc.
K832384Bp Transducer Holders Th-2,3 & 4American BentleyDXOClass II
K832279Peripheral Transluminal ArgioplastySontek Corp.
K832160Electro-PulseElectro-PulseGZJClass II
K831638Single Bed Arrhythmia Monitor Am500Lifeline Systems, Inc.DSIClass II
K831351Permalux Visible Cure Composite RestorLares Manufacturing Co., Inc.EBFClass II
K833012InspirometerKinetixBWFClass II
K831988Intravascular CatheterC.R. Bard IncFOSClass II
K833508Prepared Macconkey AgarLavco Laboratory, Inc.JSIClass I
K833470Pacemaker Evaluation Module-330Marquette Electronics, Inc.DPSClass II
K833410Monospherical Glenoid Prosth. KeelHowmedica Corp.KWSClass II
K833409Monospherical Resurfacing Glenoid ProsHowmedica Corp.KWTClass II
K833344Auto-LancetPalco Laboratories, Inc.FMKClass II
K833300Sabouraud Bhi AgarNeogen Culture MediaJSCClass I
K833299Brucella Agar ModifiedNeogen Culture MediaJSGClass I
K833249FitnessFitness Equipment Co., Inc.IONClass I