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Shiley Specialized, Pediatric & Neonatal Trach.tube

by Sorin Biomedica, Fiat, USA, Inc.

510(k) K925615

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK925615 Date26 Mar 1993ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1511-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010 on shared 510(k) K925615
    • Terminated Z-1514-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010 on shared 510(k) K925615
    • Terminated Z-1513-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010 on shared 510(k) K925615
    • Terminated Z-1510-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010 on shared 510(k) K925615
    • Terminated Z-1512-2010 FDA Unclassified (pre-2012) initiated 13 Apr 2010 on shared 510(k) K925615

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

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  • Withdrawn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
CBI
Device Class
Class II
Regulation
21 CFR Part 868.5740
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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