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Tracheolife

by Mallinckrodt Medical

510(k) K941535

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K941535; other models may be affected

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 NumberK941535 Date15 Apr 1994ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1868-2021 FDA Class II initiated 29 Apr 2021 on shared 510(k) K941535

    The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

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  • Withdrawn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
BYD
Device Class
Class I
Regulation
21 CFR Part 868.5375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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