510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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
46,018 of the 176,415 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
20262,618
176,415 records, page 3028 of 3529
510(k) clearances, page 3028 of 3529
K numberDeviceApplicantProduct codeClassDecision date
K843758Uropaper Eiken GkSyn-Kit, Inc.JILClass II
K843757Uropaper Eiken AgSyn-Kit, Inc.JILClass II
K843756Uropaper Eiken 5Syn-Kit, Inc.JILClass II
K843755Uropaper Eiken 6BSyn-Kit, Inc.JILClass II
K843754Uropaper Eiken 7Syn-Kit, Inc.JILClass II
K843753Uropaper Eiken GpSyn-Kit, Inc.JILClass II
K842856Landers-Foulks Temp. KeratoprosthesisOcular Instruments, Inc.MLPClass II
K844757Tubing HolderProcter & Gamble Mfg. Co.
K844612Acute Hemodialysis TraysPackaging Technologies, Inc.KNZClass II
K844557Ackrad Endotracheal Tube Introducing GuideAckrad LaboratoriesBSRClass I
K844495Medipart Xenon Breathing Kit Mp-02XmMedipart Jerry AlexanderIYTClass II
K844420Med-Life Emergency Oxygen Regreather/resuscitatorMed-Life, Inc.BTMClass II
K844417Appose Ultra Dispos. Skin Stapler W/auto ReleaseDavis & Geck, Inc.GAGClass II
K844411Scrub Mate Dry Sterile Scrub BrushAmerican Sterilizer Co.GECClass I
K844280Travenol Value-Line Urinary Drainage Bag W/sterileTravenol Laboratories, S.A.KNXClass II
K844160VentiboxSyncor Intl. Corp.KPYClass I
K844121Clamp, Tubing, LineDyn-A-Med ProductsFKKClass I
K844015Cerebral Tracer 1500 & CT 1.0 SoftwareCns, Inc.GWSClass I
K843928Counterbalanced Vertical Cassette HolderPoersch Metal Mfg. Co.IYBClass I
K843927CT 9000General Electric Co.JAKClass II
K843926Prestilix 1690Cgr Medical Corp.IXRClass II
K843918Corometrics Fetal Monitor 142GE Medical Systems Information Technologies, Inc.HGMClass II
K843805Coulter Check Sample Unassayed HematologCoulter Electronics, Inc.JPKClass II
K843716Nuclear 700 Medicine Mechanical Posit-Technicare Corp.IYXClass I
K843698Closed Urinary Drainage UnitPathfinder Intl. Corp.KNXClass II
K843695Qca Hemoglobin KitBD Becton Dickinson Vacutainer Systems PreanalyticKRZClass II
K843547Pace *Aid Model 52Cardiac Resucitator Corp.DROClass II
K843349Nd3100 Video ImagerNuclear Data, Inc.LMBClass I
K843264Monoject Menghini Soft Tissue BiopsySherwood Medical Co.FMIClass II
K844628V. Mueller Pheumo-Intestinal Instrument SetAmerican V. MuellerGAGClass II
K844600Slip Joint PliersMed-Tool, Inc.HTCClass I
K844599Diagonal Pin CutterMed-Tool, Inc.
K844159Api Uniscept Mic 100UlAnalytical Products, Inc.LTWClass II
K844153Concep-7-Bhcg (Eia)Leeco Diagnostics, Inc.JHIClass II
K843936Montgomery Safe-T-TubeBoston Medical Products, Inc.BTRClass II
K843498Bipolar Suction ElectrodeEder Instrument Co, Inc.GETClass I
K833928MyopulseBiomedical Design InstrumentsIPFClass II
K833085Staple Remover Sr300pProsper, Inc.GDTClass I
K844591Mist-Ease NebulizerGeneral Physiotherapy, Inc.CCQClass I
K844288Inra Menezo B2 MediaFcs Laboratories, Inc.KITClass I
K844276E-Coli-Chek TubeE-Y Laboratories, Inc.JTOClass I
K844020Pyridoxal DiscRemel IncJTOClass I
K843884General Utility Tray SystemApplied Medical Devices, Inc.
K843883Sterile Percutaneous Transhepatic CholanApplied Medical Devices, Inc.
K843789Ultra & Ultra MinatureQualitoneESDClass I
K843782Dry TrayE.M. Adams Co., Inc.EFQUnclassified
K843573Civco-Super Scan/biopsy GuideCIVCO Medical Instruments Co., Inc.ITXClass II
K842900Philips Sdr 1200Philips North America LLCIYOClass II
K841430LaserspecClement Clarke, Inc.
K844720Ggt Procedure or Gamma Glutamyl Transferase ProcedData Medical Associates, Inc.JQBClass I