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Pediatric Cuffed and Uncuffed Et Tubes; Standard Cuffed and Uncuffed Et Tubes

by Vitaid, Ltd.

510(k) K050803

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK050803 Date30 Jun 2005ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1144-2007 FDA Unclassified (pre-2012) initiated 4 Jun 2007
    • Terminated Z-1143-2007 FDA Unclassified (pre-2012) initiated 4 Jun 2007

    The tubes may kink during use which may impede or prevent ventilation.

    • Terminated Z-1263-06 FDA Unclassified (pre-2012) initiated 19 Jun 2006

    Inadequate seals and/or holes in the pouch may compromise the sterility of the product.

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  • Withdrawn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
BTR
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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