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 3082 of 3528
510(k) clearances, page 3082 of 3528
K numberDeviceApplicantProduct codeClassDecision date
K840801Dia-H 1/2/3 & Dia-Ht 1/2/3Diatech, Inc.
K840721Perio PikTeledyne, Inc.EFSClass I
K840690Dental HandpiecePen-Med Technology, Inc.EFBClass I
K840558Shutt Precision ProbesConcept, Inc.HXBClass I
K840486Total Bilirubin ReagentSomas Medical Industries, Inc.CIGClass II
K840434Replace-a-Tip Low Temp. CauterySuncoast Medical Manufacturers, Inc.GEIClass II
K840433Replace-a-Tip High Temp. CauterySuncoast Medical Manufacturers, Inc.GEIClass II
K840408Linear Array Transducer or ScanheadAdr UltrasoundIYOClass II
K840324Silicone Sump Drain 20 & 40 FrenchSuperior Plastic Products Corp.JCYClass I
K840323Silicone Suction & Irrigation DrainSuperior Plastic Products Corp.GBXClass I
K840254Diamond LustreJelrus Technical Products Corp.EJRClass I
K840206Pressure Sentry TourniquetRichards Medical Co., Inc.KCYClass I
K840197Single Lumen Subclavian CannulaShiley, Inc.LFJClass II
K840145Monitor CO2 Laser Surgical SystemCooper Lasersonics, Inc.HQFClass II
K840138Qta Processor ModuleGeneral Electric Co.IYOClass II
K840107Tube-Bandage for Human Digits 200Zens Health Care ProductsFQMClass I
K840090Vilene Surgical Mask 5505Hall-Tech
K840008O'neil Obstetric CupGo Medical Industries Pty., Ltd.HDBClass II
K834434Mach I Electrosurgery Hand ControlSurgical Products Corp.GEIClass II
K834280Sdl-30Shimadzu Corp.IYOClass II
K834239Sdi C-Flex Sterile Light HandleSterile Design, Inc.
K833797Light Cured Resin Bonded Ceramic3M CompanyEBFClass II
K833491Endo Bite BlockAmerican Endoscopy, Inc.KTIClass II
K832550Sharplan #734 Laser Surgical UnitLaser Industries, Ltd.GEXClass II
K831404Blood Monitor Bmm 10-4Gambro, Inc.LLBClass II
K841496Fraser Harlake Hope III ResuscitatorFraser Harlake, Inc.BTMClass II
K841469Misty Ox Dispos. NebulizerMedical Molding Corp. of AmericaCCQClass I
K841360Minor Surgical Light Model 180American Sterilizer Co.FTDClass II
K841320Percutaneous Trig. Finger Release KnifeAnapach Effort, Inc.GESClass I
K841283Disposable Suction Tubing SetAesthetech Corp.
K841278Omnistim III Interferential TherapyPhysio Technology, Inc.IPFClass II
K841150Vascular-Access Port Change CatheterNorfolk Medical Products, Inc.LJTClass II
K841149Vascular-Access Port - EnlargementNorfolk Medical Products, Inc.LJTClass II
K841086Surgical Instrument DemagnetizerScanlan Intl., Inc.
K840993Transcutaneous 800-Oxygen Monitors/801Novametrix Medical Systems, Inc.KLKClass II
K840939Emit Qst Primidone AssaySyva Co.DJDClass II
K840922Intradiscal Therapy Needle 18 GaugeDlp, Inc.GAAClass I
K840913Provac Wound Drainage & Healing SysMeyer Medical U.S.A., Inc.GCYClass I
K840895Electrical Neuro-Muscular StimulatorRichards Medical Co., Inc.IPFClass II
K840806Fr Medical X-Ray FilmFr Medical/Fr ChemicalsIWZClass I
K840797Male-Male Luer Lock Connector W/rotaAmerican Pharmaseal Div. AhscDTLClass II
K840788Vascular Access Port Changes in MaterNorfolk Medical Products, Inc.LJTClass II
K840728Hearing Aids in-the-EarHearing Instruments, Inc.ESDClass I
K840720Fiber Hemofilters Fh55-Fh77 & 88Gambro, Inc.KOJClass II
K840610Scimed Model Sc4000Scimed Life Systems, Inc.DTPClass II
K840373Flexible Illuminator 10Suncoast Medical Manufacturers, Inc.FTFClass II
K840372Flexible Illuminator 15Suncoast Medical Manufacturers, Inc.FTFClass II
K840371Flexible Illuminator 5Suncoast Medical Manufacturers, Inc.FTFClass II
K840322Hemofiltration Catheter HF-100Vas-Cath of Canada, Ltd.FIQClass II
K840158Kosmedico Gmbh Sunlamp ProductsKosmedico, Kosmetische & MedizinischFTCClass II