510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK 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
46,132 of the 176,529 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
20262,732
176,529 records, page 1570 of 3531
510(k) clearances, page 1570 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K012236Stars2000 Power CannulaKmi Kolster Methods, Inc.QPBClass II
K011322Dornier Sapphireerbium Handpiece, Dornier Sapphirespot HandpieceDornier Medtech America, Inc.GEXClass II
K013709Hill-Rom Primaview Monitor SystemHill-Rom Inc.FETClass II
K013627Sonoace Sa-8000 Diagnostic Ultrasound SystemMedison America, Inc.IYNClass II
K013557Lactosorb Craniofacial Anchor-Push ScrewBiomet MicrofixationMBIClass II
K013503Modification to: Sterile Colles Classic FixatorDepuy Orthopaedics Inc.KTTClass II
K013499Diomed 15 Plus and Diomed 30Plus LasersDiomed, Inc.GEXClass II
K013480Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorLivaNova USA, Inc.DTZClass II
K013468Long Length Dyax NailHowmedica Osteonics CorpHSBClass II
K013444Isobar Spinal SystemScien'Tx USA, Inc.MNHClass II
K013441Isola Polyaxial WasherDepuyacromedKWPClass II
K013440Isobar Spinal SystemScien'Tx USA, Inc.MNIClass II
K013274Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,sterileCp MedicalNEWClass II
K013249Tina-Quant Apolipoprotein Ver.2Roche Diagnostics GmbHDERClass II
K013206Tina-Quant Apolipoprotein B Ver.2Roche Diagnostics GmbHDFCClass II
K013203Bioscanner Beyond Glucose Analyzer and Test StripsPolymer Technology SystemsNBWClass II
K013119Validate Chem 6 Calibration Verification Test Set Model # 10006Maine Standards Co.JJXClass I
K013101Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.amilasa 405 Cinetica Unitest,wiener Lab.amilasa Cinetica AaWiener Laboratories SaicJFJClass II
K013095Wiener Lab.fosfatemia UV, Models 1X100 Ml Cat.n 1382321, 4X20 Ml Cat.n 1009311Wiener Laboratories SaicCEOClass I
K013082Medstar 100 Interferential StimlatorMednet Services, Inc.LIHClass II
K012896Sterile Powdered Latex Surgical Gloves with Protein Labeling Claim (200 Micrograms or Less)Ssn Gloves (M) Sdn BhdKGOClass I
K012880Sterile Powder-Free Latex Surgical Gloves (50 Micrograms or Less)Ssn Gloves (M) Sdn BhdKGOClass I
K012856Sterile Latex Examination Gloves (Powdered) with Protein Claim Less Than 100Ug/gSmart Glove Corp. Sdn BhdLYYClass I
K012853Smart Glove Sterile Nitrile Exam GloveSmart Glove Corp. Sdn BhdLZAClass I
K012833Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc.NAYClass II
K012819Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9Semperit Technische Produkte GesellshaftKGOClass I
K012798Intex ScrewZimmer GmbHHWCClass II
K012790Cynosure Photogenica ErCynosure, LLCGEXClass II
K012785Twintrode Elc 134 ElectrodeHealthtronics Surgical Services, Inc.LNSClass II
K012776Duracon Constrained Posterior Stabilized (Ps) Tibial InsertHowmedica Osteonics CorpJWHClass II
K012774Jostra Arterial Perfusion CannulaeJostra AGDWFClass II
K012773Discovery Facet Screw Fixation SystemDepuyacromedMRWUnclassified
K012585Ameditech Immutest Drug Screen MethamphetamineAmeditech, Inc.LAFClass II
K012197Powerheart Cardiac Rhythm ModuleZOLL Medical CorporationMKJClass III
K011586Irma Sl Blood Analysis System Gl CartridgeDiametrics Medical, Inc.GAAClass I
K011556Macs Hma Anterior Spinal Stabilization SystemAesculap IncKWQClass II
K011473Snazzy2Shoprider Intl., Inc.INIClass II
K011122Ballpen Spinal Needle W/wo IntroducerRusch Intl.BSPClass II
K011121Rusch Percutaneous Nephrostomy Catheter SetsRusch Intl.LJEUnclassified
K010601Fanelli Biliary StentCook Inc.FGEClass II
K013608Digital Radiography System, Model Dfp-8000DToshiba America Medical Systems, In.COWBClass II
K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc.DAPClass II
K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc.DAPClass II
K013526Capiox Rx Hardshell ReservoirTerumo Cardiovascular Systems CorporationDTNClass II
K013463Arthrocare Arthro Wands, Enetec Evac Plasma WandArthroCare CorporationGEIClass II
K013431Pass Spinal SystemEncore Orthopedics, Inc.MNIClass II
K013278Tina-Quant Apolipoprotein a-1 Ver.2Roche Diagnostics GmbHDELClass I
K012763Sorin Biomedica Smart Bcd Vanguard,surface Modified Blood Cardioplegia SystemLivaNova USA, Inc.DRTClass II
K012752Wallstent Rx Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific CorporationFGEClass II
K012544Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemVascular Architects, Inc.JCTClass II