Skip to content

Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube and Disposable Inner Cannula

by Mallinckrodt, Inc.

510(k) K003315

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK003315 Date8 Nov 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1312-04 FDA Unclassified (pre-2012) initiated 8 Jul 2004 on shared 510(k) K003315

    Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

Other devices from Mallinckrodt, Inc.