Skip to content

Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed

by Mallinckrodt Medical

510(k) K955680

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 · Traditional NumberK955680 Date13 Mar 1996ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1495-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1498-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1493-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1496-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1494-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1499-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1492-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010
    • Terminated Z-1497-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010

    Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Mallinckrodt Medical

See all devices from Mallinckrodt Medical →