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 3479 of 3526
510(k) clearances, page 3479 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K771291Image Scanning Type Sonolay. Sal-10AToshiba Medical SystemsIYOClass II
K771261AdvansetC.R. Bard IncDRCClass II
K771231Arteoial Line KitMedical Disposables Intl., Inc.DQXClass II
K771230Percutaneous Introducer Sheath SetMedical Disposables Intl., Inc.DQXClass II
K771197Norton EndotrachealV. Mueller O.V. Baxter Healthcare Corp.BTRClass II
K771176Gothic Arch TracingDentsply Intl.KZOClass I
K770717Iontophoresis System Module, Dm 500Sorensen ResearchEGJClass II
K771446Transporteo ModuleHyland Therapeutic Div., Travenol LaboratoriesJQXClass I
K771353Platelet Counter & Hematocrit Acces.Hycel, Inc.GKLClass II
K771343Ldh-Int TestHycel, Inc.CFHClass II
K771341Spinsep-TbgNuclear Diagnostics, Inc.CEEClass II
K771323Electrophoresis Oven ThermometerCorning Medical & ScientificJJNClass I
K770924Green Radiopaque in Surg. SpongesKendall Research CenterGDYClass I
K771039Respirator, Protable, Volume ControlledDept. of the NavyCBKClass II
K771447Pregelled Disp. EKG Monitoring Elect-Hayes Products, Inc.DRXClass II
K771408Wrought (Forged) VitalliumHowmedica Corp.LZNClass II
K771407Lung Volume & Pressure MonitorResearch Development Corp.BZQClass II
K7713852 Jet SetBD Becton Dickinson Vacutainer Systems PreanalyticBYFClass I
K771374Scanner Trend SystemInstruments for Cardiac ResearchDSIClass II
K771372System IIIrex Corp.DSFClass I
K771371Screening Computeo Sc-20Cavitron Corp.BZMClass II
K771368Portable Infant VentilatorCavitron Corp.FOCClass II
K771361Physiological Pressure Transducer 1290AHewlett-Packard Co.DRSClass II
K771360ECG Scope Model 7833Hewlett-Packard Co.DRTClass II
K771345Bichromatic Analyzer Aba-200Abbott MedicalJJEClass I
K771307Bain Breathing CircuitRespiratory Care, Inc.CAIClass I
K771305Liquaemin Sodium, Heparin Sodium Etc.Organon LLCGIMClass II
K771304Liquaemib Sodium Preservative, Etc.Organon LLCGIMClass II
K771301Digital Radiation DetectorActus, Inc.IZDClass I
K771299Emergency Oxygen ResuscitatorFraser Sweatman, Inc.BTLClass II
K771222Tsh Ria Test SystemMonobind, Inc.JLWClass II
K771221T4 Ria Test SystemMonobind, Inc.CDXClass II
K771220T3 Ria Test SystemMonobind, Inc.CDPClass II
K771219Broncho-CathMallinckrodt Critical CareBTSClass II
K771217Anesthesia RespiratorRule Medical Instruments, Inc.BZDClass II
K771155Anti-MitochondrialMeloy Laboratories, Inc.DBEClass II
K771151Artius SystemGeneral Electric Co.HGLClass II
K771150Copper Kettle Vaporizer PlusAir Products & Chemicals, Inc.CADClass II
K771138Pipets Borosilicate GlassDade, Baxter Travenol Diagnostics, Inc.GJWClass I
K771137Pipets Uniform Drop Size BorosilicateDade, Baxter Travenol Diagnostics, Inc.GJWClass I
K771129Auto-Logic II SystemAbbott MedicalJJJClass I
K771122Veri/ctgs Model 850Verite Scientific, Inc.GZJClass II
K771098Blood Grouping Sys., Bg-9Technicon Instruments Corp.KSZClass II
K771085Dynazyme II Alkaline PhosphataseJ.T. Baker Chemical Co.CJEClass II
K771084Dynazyme II Y-GtJ.T. Baker Chemical Co.
K771075Oxygen Connecting Tube #017205C.R. Bard IncBYXClass I
K771074Nasal Oxygen Cannula, #017207C.R. Bard IncCATClass I
K771034Hi-Mid CurcuitDraeger, Inc.CAIClass I
K771033Smac Sys., Supplemental Products forMid Tech, Inc.CKAClass I
K770973Cardiozyme Ck Control NormalDade, Baxter Travenol Diagnostics, Inc.JJTClass I