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Bivona Wire Reinforced Pediatric Tracheostomy Tube

by Bivona Medical Technologies

510(k) K912469

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

28 ongoing

This device is named in the recall

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 NumberK912469 Date19 Jun 1991ClearedStatusActive

Recalls

44 recalls · 28 ongoing · FDA

  • 28 recalls, same reason

    • Ongoing Z-2602-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2606-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2613-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2612-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2605-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2611-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2589-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2599-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2590-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2591-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2595-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2596-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2597-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2592-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2610-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2608-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2607-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2609-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2588-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2604-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2598-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2593-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2614-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2615-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2600-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2601-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2603-2024 FDA Class I initiated 29 May 2024
    • Ongoing Z-2594-2024 FDA Class I initiated 29 May 2024

    Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

  • 16 recalls, same reason

    • Terminated Z-0671-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0665-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0660-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0664-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0659-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0668-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0657-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0670-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0666-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0669-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0658-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0667-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0663-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0661-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0656-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011
    • Terminated Z-0662-2012 FDA Unclassified (pre-2012) initiated 28 Nov 2011

    Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is imm

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
BTO
Device Class
Class II
Regulation
21 CFR Part 868.5800
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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