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 3316 of 3528
510(k) clearances, page 3316 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K802543Ridgid Vena Cava CannulaeTexas Medical Products, Inc.DWFClass II
K802542Disposable ConnectorsTexas Medical Products, Inc.KRIClass I
K802541Disposable Parallel Y ConnectorsTexas Medical Products, Inc.KRIClass I
K802539Disposable Gas Line FilterTexas Medical Products, Inc.KRIClass I
K802361Dialyis Start Care KitMed-Pak Corp.FKGClass I
K801771Alpha-Thal Screen 20 Test Kit & 100 KitIsolab, Inc.LGLClass II
K810034Foot Baths & Hand MassagersAssociated Mills, Inc.ILJClass II
K810007Pentax Upper G.i. Fiberscope, #Fg-34Pentax Precision Instrument Corp.GDBClass II
K803299Cold/hot PackW.G. Whitney Corp.IMEClass I
K803269Capsule Dental AmalgamDentsply Intl.
K803261T3 Riabead Diagnostic KitAbbott MedicalCDPClass II
K803258Cordis Hakim Ascites Valve SystemCordis US Corp.KPMClass II
K803214Acmi Bipolar Hemostatic ElectrodeAmerican Cystocope Makers, Inc.FEHClass II
K803207Regulator, Oxygen MechanicalTimeter Instrument Corp.CANClass I
K803199Suture Removal KitWalpak Co.KDDClass I
K803198Irrigation Set W/piston SyringeWalpak Co.FMFClass II
K803188Gauze SpongesAbco Dealers, Inc.GDYClass I
K803172Gauze SpongesWorldwide Surgical GauzeEFQUnclassified
K803158Irradiated Boundary DevicesThe Buckeye Cellulose Corp.FYAClass II
K803156Surgitek Medi-LoopsMedical Engineering Corp.KDCClass I
K803131Lkb-Wallace 1250 LuminometerLkb Instruments, Inc.JJQClass I
K803125Bone-Dri Surgical SpongeHowmedica Corp.NABClass I
K802972Dual-TrolCimarron Instruments, Inc.GEIClass II
K802943Positive End Expiratory Pressure ValveFraser Harlake, Inc.BYEClass II
K802940Super-Spike Transfer SetGeneva Laboratories, Inc.KSBClass II
K802905Multi-Image Camera-#627 TlcDunn Systems, Inc.IYOClass II
K802885L.a.f. Isolation PackAction Medical Systems, Inc.FYAClass II
K802829Scanlan Vascu-StattScanlan Intl., Inc.FMPClass I
K802801Ge Rt/plan Magnetic Tape Drive OptionGeneral Electric Co.KPSClass II
K802437Mark III Ultrasonic Scanning SystemAdvanced Technology Laboratories, Inc.IYOClass II
K802406Cytotran I Bone Marrow Aspiration SystemApplied Medical Devices, Inc.FMFClass II
K810030Post-Auricular Hearing Aid (#Pe830)Hc ElectronicsESDClass I
K803316Orthodontic BracketOrec Corp.EJFClass I
K803310Ceramco PorcelainJohnson & Johnson Professionals, Inc.EIHClass II
K803227Visio-DispersEspe-Premier Sales Co.EBFClass II
K803209Elipar Light SourceEspe-Premier Sales Co.EBZClass II
K802975Anterior/posterior Composite RestorativeDentsply Intl.EBFClass II
K803307Mattress, Air Floatation, Altern. Press.Intl. Medical Equipment Corp.FNMClass II
K803277Tygon TubingElectromedics, Inc.DWEClass II
K8032294-Channel ECG Telemetry Mon. Syst. #3045Cambridge Instruments, Inc.DRGClass II
K803225Advancemed ExaminerAmerican Edwards LaboratoriesDSFClass I
K803224Advancemed Holter RecordersAmerican Edwards LaboratoriesDSHClass II
K803223Advancmed EliminatorAmerican Edwards LaboratoriesDRTClass II
K803222Advancemed Ccu DocumentorAmerican Edwards LaboratoriesDSHClass II
K803142Conphar Velcro TouniguerConphar, Inc.GAXClass I
K803123Crt Display #1310BHewlett-Packard Co.DXJClass II
K803096Narco Telecare Transducer Dome #700-4000Narco ScientificDRSClass II
K803061Sun Tanning DevicesMutzhas Corp.LEJClass II
K803057Fogarty Ballon Angioplasty CathetersAmerican Edwards LaboratoriesLITClass II
K802850Tecnol o.r. Tourniquet CoverTecnol New Jersey Wound Care, Inc.EYRClass I