Cleared Traditional

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)

K250173 · Covidien, LLC · Anesthesiology
Oct 2025
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K250173 is an FDA 510(k) clearance for 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), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on October 6, 2025, 258 days after receiving the submission on January 21, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K250173 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 2025
Decision Date October 06, 2025
Days to Decision 258 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

Similar Devices — BTR Tube, Tracheal (w/wo Connector)

All 239
Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced
K243785 · Covidien, LLC · Sep 2025
AeroJet Ventilation Catheter
K243579 · Pipeline Medical Products, LLC · Aug 2025
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
K251499 · William Cook Europe Aps · Jun 2025
ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
K250243 · Flexicare Medical Limited. · May 2025
LMA Fastrach ETT SU
K242495 · Teleflex Medical · Apr 2025
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
K241451 · Teleflex Incorporated · Feb 2025

More from Covidien, LLC

View all
Mon-a-Therm? Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025 · BZT · Dec 2025
Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Distal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Disposable Inner Cannula XLT
K251313 · JOH · Dec 2025
Hugo? RAS System
K250725 · SCV · Dec 2025
Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced
K243785 · BTR · Sep 2025
Valleylab ?FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
K241085 · GEI · Jul 2024