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 3323 of 3528
510(k) clearances, page 3323 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K801634The Vita 2 Disposable DialyzerBellco Artifidial Organ Spec., Inc.FHSClass II
K802906William Harvey Oxygenating Gas FilterC.R. Bard IncKRIClass I
K802897Electronic Digital ThermometerPhilip J. TedersKPDClass II
K802887Model EEG 4221Nihon Kohden America IncGWQClass II
K802875Argyle Hematuria Balloon CatheterSherwood Medical Co.KODClass II
K802849Tecnol Telemetry Unit PouchTecnol New Jersey Wound Care, Inc.DRGClass II
K802847Oxygen Saturation Meter Model No. Sm-1Bentley Laboratories, Inc.
K802783Surgeons Choice Staple, Remove/implantHospital Products Intl.GBNClass I
K802775Fiber Optic Adapter #60-0896Aspen Laboratories, Inc.EQHClass I
K802774Fiber Optic Adapter #60-0892Aspen Laboratories, Inc.EQHClass I
K802773Fiber Optic Light Guide #60-0767Aspen Laboratories, Inc.EQHClass I
K802772Fiber Optic Adapter #60-0894Aspen Laboratories, Inc.EQHClass I
K802771Fiber Optic Adapter #60-895Aspen Laboratories, Inc.EQHClass I
K802768Fiber Optic Adapter #60-0897Aspen Laboratories, Inc.EQHClass I
K802767Fiber Optic Light Guide Cat#60-0768Aspen Laboratories, Inc.EQHClass I
K802766Fiber Optic Adapter Cat#60-0898Aspen Laboratories, Inc.EQHClass I
K802720Spiraflo Blood Oxygenators Model Bos-5SBentley Laboratories, Inc.DTZClass II
K802719Spiraflo Blood Oxygenators Model Bos-10SBentley Laboratories, Inc.DTZClass II
K802667Argyle Closed Urinary Drainage SetSherwood Medical Co.KNXClass II
K802662Polycarbonate Temporary CementBuffalo Dental Mfg Co IncEMAClass II
K802627Ortron 90* Hip ProsthesisCintor Orthopaedic Div.JDIClass II
K802571Cye Biphasic Blood Culture MediumRemel Co.JSJClass I
K802513Dpa 207 PersonalHill, Farrer & BorrillKCXClass I
K802462Synthes Spinal Implant SystemSynthes (USA) Products LLCKWPClass II
K802412Blood Pressure Unit Model 410Js & A GroupDXNClass II
K802411Blood Pressure Unit Model 310Js & A GroupDXNClass II
K802400Ms 16 Syringe DriverPrinceton Medical Instruments, Inc.FRNClass II
K802382Sonic EarAcousticon ElectronicsESDClass I
K801954Hp Model 77020A Ultrasound SystemHewlett-Packard Co.IYOClass II
K801879Puig Massana-Shiley Annuloplasty RingShiley, Inc.KRHClass II
K801535Lares Handpiece OilLares Manufacturing Co., Inc.EFBClass I
K800746Unifocal Vp, Models 7501 and 7502American Pacemaker Corp.DXYClass III
K802474Cmr 300, Rowater Treatment UnitU-Marc, Inc.FIPClass II
K802279Vida 55 Pulse-Echo Ultrasonic DeviceVida, Inc.EWGClass II
K803021Upper Extremity Traction DeviceMizuho Orthopedic Systems IncHSTClass I
K802892Culture Media for in Vitro Diag. UseRadiation Technology, Inc.JSGClass I
K802872Aufranc-Turner Ats Total Hip SystemHowmedica Corp.JDIClass II
K802871Tibial Fracture BraceOrthomedicsIQIClass I
K802869Backtrac 90-90 TractionBacktracKQZClass I
K802863Gauze SpongesAbco Dealers, Inc.EFQUnclassified
K802862Gauze Pads Sterile SinglesAbco Dealers, Inc.EFQUnclassified
K802861Combination Pads Sterile SinglesAbco Dealers, Inc.EFQUnclassified
K802860Post Op. Sponges SterileAbco Dealers, Inc.EFQUnclassified
K802857Immulon Removawell Strips #011-010-6301Dynatech Corp.JTCClass I
K802854Beckman Ics Drug Control SeraBeckman Instruments, Inc.DIFClass I
K802848Cardioplegia Cooling Syst. Ccas-2Bentley Laboratories, Inc.DTRClass II
K802838Sternum Saw BladeAmsco Co.GFAClass I
K802836Series 1800 Exercise TreadmillMarquette Electronics, Inc.IOLClass I
K802835Compu-Chem II Chemistry AnalyzerDiagnostic Aids, Inc.JJEClass I
K802827Bouie Electrosurgical Tip CleanerSybron Corp.GEIClass II