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Shiley Tracheosoft XLT Extended Length Tracheostomy Tube And Inner Cannula

by Mallinckrodt Medical

510(k) K051416

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051416 Date16 Jun 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JOH
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula is a medical device classified as a tracheostomy tube and tube cuff. It is designed to provide an airway for patients with anatomical challenges by offering extended length configurations in either the proximal or distal portions of the tube.

This device is authorized under FDA 510(k) clearance K051416. It features a disposable inner cannula to assist with maintenance and is intended for use in adult patients requiring extra length for a customized fit.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Shiley Tracheosoft XLT?

    This device is designed to provide an airway for adult patients who have specific anatomical challenges. It offers extended length configurations in either the proximal or distal portions of the tube to ensure a customized fit.

  • Does this tracheostomy tube include an inner cannula?

    Yes, the device includes a disposable inner cannula. This feature is intended to assist with the maintenance of the tracheostomy tube during use.

  • What is the regulatory status of this device?

    The Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Inner Cannula is authorized under FDA 510(k) clearance K051416.