FDA cleared the Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) from Covidien, LLC on Oct 6, 2025 under K250173, a traditional 510(k). The device falls under product code BTR, Tube, Tracheal (W/Wo Connector), regulated at 21 CFR 868.5730 as a Class 2 device. The review panel was Anesthesiology.
FDA logged the submission as received on Jan 21, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Covidien, LLC has 8 other decisions in the tracker over the last 12 months: K260907 (BIS Advance pEEG Module), K253527 (Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)), K253984 (Instrument Exit Point on Touch Surgery Aide), K253030 (Capnostream35 Portable Respiratory Monitor (PM35MN)).