Cleared Traditional

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 · Covidien, LLC · Anesthesiology
Dec 2025
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K251313 is an FDA 510(k) clearance for the 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, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 29, 2025, 245 days after receiving the submission on April 28, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K251313 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date December 29, 2025
Days to Decision 245 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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