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 2334 of 3531
510(k) clearances, page 2334 of 3531
K numberDeviceApplicantProduct codeClassDecision date
K923834Tracheostomy Care Set with GlovesAmerican Healthcare Corp.BTOClass II
K923348Ophthalmic A/b Scan System, Model 835 -- ModifiedZeiss Humphrey SystemITXClass II
K9231603DscopeAmerican Surgical Technologies Corp.FWFClass I
K922865Neer Type Shoulder Prosthesis SystemOsteo Technology, Inc.KWTClass II
K922706Scimed SidelinerScimedDQXClass II
K922550Romas (Range of Motion Assessment System)Verimed Holdings, Inc.KQXClass I
K922536Torque DeviceProcedure Products, Inc.DQXClass II
K922396Fujinon Forceps -- ModificationHobbs Medical, Inc.FCLClass I
K922378Ophthalmic KnifeMicroptics Development LaboratoryHNNClass I
K915550Mini Doppler II Ultrasound Blood Flow DetectorKoven and Assoc., Inc.DPWClass II
K924759Collimator Light SourceDenar Corp.IZTClass II
K924733Ethyl Alcohol Calibrators & ControlDiagnostic Reagents, Inc.DNNClass II
K921946Tum-E-Vac Bite BlockEthox Corp.JXLClass II
K924987Taper GuidewiresTarget TherapeuticsDQXClass II
K924712Rotablator Rotational Angioplasty SystemHearing Tech, Inc.MCWClass II
K924643Medtronic Bio-Medicus Cannula Insertion KitMedtronic Bio-Medicus, Inc.DWFClass II
K924591Schneider Solid-7 Soptip Guiding CatheterSchneider Intl., Ltd.DQYClass II
K924551Endo Trachea Tube FixationM. Imonti and Associates Inc.CBHClass I
K924311Sonomed 4000P Ultrasonic PachymeterSonomed, Inc.IYOClass II
K923519Sensor GuiHospitronicBSZClass II
K92257310 and 20 Cc Inflation/deflation Devices W/gaugeBoston Scientific CorporationMAVClass II
K922541Usci Super 9 Ptca Guiding CatheterC.R. Bard IncDQIClass II
K922218Iq SystemRenaissance Technology, Inc.DXGClass II
K915869Rmi Normocluder Coronary Artery OccluderResearch Medical, Inc.MJNClass II
K915827A.c.s. Suture Removal KitAmerican Carolina StampingMCZClass I
K915741Disposable Monoplar Meddle ElectrodesDantec Medical, Inc.GXEClass I
K925170Shimadzu X-Ray Tube Stand Bh-100 SeriesShimadzu Medical SystemsIYBClass I
K924877OptitrackPhilips North America LLCKPSClass II
K924625Cytoquant Hlnfs Cells, Catlog #03-151Proteins Intl., Inc.KIRClass I
K924624Cytoquant a-549 Cells, 16X125 Mm Tube #01-201Proteins Intl., Inc.KIRClass I
K924623Cytoquant a-549 Cells, Catalog #03-201Proteins Intl., Inc.KIRClass I
K924622Cytoquant a-549 Cells, Catalog #02-201Proteins Intl., Inc.KIRClass I
K924621Cytoquant Mrc-5 Cells, Catalog #02-101Proteins Intl., Inc.KIRClass I
K924620Cytoquant Mrc-5 Cells, Catalog #03-101Proteins Intl., Inc.KIRClass I
K924619Cytoquant Mrc-5 Cells 16 X 125 Mm Tube, #01-101Proteins Intl., Inc.KIRClass I
K924618Cytoquant Hep-2 Cells 25Cm/75cm/175cm Flask#03-251Proteins Intl., Inc.KIRClass I
K924617Cytoquant Hep-2 Cells 16 X 125 Mm Tube, #01-251Proteins Intl., Inc.KIRClass I
K924616Cytoquant Hep-2 Cells, Catalog #02-251Proteins Intl., Inc.KIRClass I
K924615Cytoquant H292 Cells 25Cm2/75cm2/175cm2 FlaskProteins Intl., Inc.KIRClass I
K924614Cytoquant H292 Human Pulm Mucoepider Carcin CellsProteins Intl., Inc.KIRClass I
K924613Cytoquant Mccoy Cells 25Cm2/75cm2 Flask/#03-301Proteins Intl., Inc.KIRClass I
K924612Cytoquant Mccoy Cells/one Dram Shell Vial #02-301Proteins Intl., Inc.KIRClass I
K924595Cytoquant Hnfs CellsProteins Intl., Inc.KIRClass I
K924552Du Pont Compact Daylight System II (Cds II)E.I. Dupont de Nemours & Co., Inc.IXWClass II
K924332Accutex Crp Latex TestJ.S. Medical Assoc.DCKClass II
K924247Accutex Aso Latex TestJ.S. Medical Assoc.GTQClass I
K923879Assay Software for Dpc-Marj5 Alastat Eia SoftwareSiemens Healthcare Diagnostics Inc.JQWClass I
K923754Misty Ox Laminar Diffuser HumidifierMedical Molding Corp. of AmericaBTTClass II
K923602Absorbent Pad -- ModificationWinfield Laboratories, Inc.NABClass I
K923583Orthomet Perfecta Total Hip SystemOrthomet, Inc.LZOClass II