510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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
45,902 of the 176,299 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
20262,502
176,299 records, page 3497 of 3526
510(k) clearances, page 3497 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K770295Abdominal ECG Processor for Fetal Moni.Brattle Instrument Corp.HGIClass II
K770292Monitor, Fetal Heart, Model 1980Berkeley Bio-EngineeringHGIClass II
K770276Electrotherapy Apparatus E.t. 720Fort & Assoc.IPFClass II
K770248Argyle Rapid Gastric Lavage KitSherwood Medical IndustriesKDHClass II
K770212Prolith Model 21S Cardiac Pulse Gen.Edwards Pacemaker SystemsDXYClass III
K770081Band-Aid Brand of Adhesive BandagesJohnson & Johnson Professionals, Inc.FPXClass I
K770382Needle, Fistula, ErikaErika, Inc.KOCClass II
K770355Pipettor W/detipperSherwood Medical IndustriesJQWClass I
K770350Dialysis Delivery Sys., Ultim. Model IIVital Systems, Inc.FKPClass II
K770348Trocar Sleeve System, ExtendedRichard Wolf Medical Instruments Corp.GCJClass II
K770345X-Ray Tube - PanobeamThoro-Ray, Inc.EAPClass II
K770392Muffler, Air PumpCutter Laboratories, Inc.CAHClass II
K770391Cover, Armboard, DisposablePrecept, Inc.BTXClass I
K770383Stopcock, One WayCobe Laboratories, Inc.KOCClass II
K770349Rigid Teaching AttachmentRichard Wolf Medical Instruments Corp.HWNClass I
K770346Orthopedic StockinetteConvertorsILGClass I
K770301Nipper, Pso4 TissueDentronix, Inc.FZTClass I
K770260Cap, Clarion Nurses or (Technic)Sherwood Medical IndustriesFYFClass I
K770259Cap, Clarion Surgeon'sSherwood Medical IndustriesFYFClass I
K770258Cap, Clarion Nurses, Style Bouffant 21Sherwood Medical IndustriesFYFClass I
K770250Gown, Surgical, SurgineSurgikos, Inc.BZQClass II
K770211Micropulse Model 20SEdwards Pacemaker SystemsDXYClass III
K770209Ecolyzer CarboximeterIadec, Inc.GHSClass II
K770002Console, Mobile for 3 Pumps W/mastsCobe Laboratories, Inc.DTQClass II
K761340Ostomy Karaya Gum PowderHowmedica Corp.EZRClass I
K761062Histo-Tek W/ Automatic CoverslipperMiles Laboratories, Inc.IEOClass I
K760942GentasakBD Becton Dickinson Vacutainer Systems PreanalyticDKDClass II
K770373Hearing Aid, Maico Db-PowerMaico Hearing Instruments, Inc.ESDClass I
K770376Filter, Nebulizer, CutterCutter Laboratories, Inc.CAHClass II
K770375Filter, Air, Cutter MainlineCutter Laboratories, Inc.CAHClass II
K770369Vacon TmDiemolding Corp.CBDClass II
K770368Oral IrrigatorClairol, Inc.
K770367Root Canal Files & ReamersCemco Tool Co., Inc.EKPClass I
K770366Isolated Electrocardiograph Model 1207Electronics for Medicine, Inc.DPSClass II
K770357Sphygmomanometer, ElectronicIshimoto Trading Co.DXNClass II
K770356Anesthesia Kit, Epidural, Single ShotArrow Intl., Inc.CAZClass II
K770342Recorder, Chart, Model 5536Hudson Oxygen Therapy Sales Co.DSFClass I
K770338X-Ray Control & X-Ray Hv GeneratorLitton Medical SystemsIZOClass I
K770337Fluoroscopic Assembly, Image Intens.Litton Medical SystemsJAAClass II
K770336X-Ray Tube, Rotating AnodeLitton Medical SystemsITYClass I
K770334Tilting X-Ray TableLitton Medical SystemsIXRClass II
K770333Fluoroscope, C-ArmLitton Medical SystemsJAAClass II
K770277Cholesterol StandardsWorthington Biochemical Corp.JITClass II
K770273Test, Ammonia, Bmc ReagentsetBoehringer Mannheim Corp.JIFClass I
K770272Uric Acid Test, Bmc AutofloBoehringer Mannheim Corp.KNKClass I
K770261Hood, Clarion SurgeonsSherwood Medical IndustriesFXYClass II
K770229Auto-Enzymatic GlucoseHarlecoCFRClass II
K770216Viral Antisera, Fluorescein LabeledFlow Laboratories, Inc.GRAClass I
K770193Pipettor, 400, Centrifichem SystemUniversal Instruments Corp.JQWClass I
K770092Herpesivirus Test (Type L & 2)Microbiological Research Corp.GOLClass II