# K083641: Bivona Tracheostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Feb 23, 2009 after 76 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081440 (2008). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081440: Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes, Smiths Medical Asd, Inc. (2008) Summary page 1.

## Most influential descendants
- K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T (2012), 2 descendants of its own
- K120079: Primed Tracheostomy Tubes (Multiple) (2012), 2 descendants of its own
- K123699: Fahl Tracheostomy Tubes (Multiple) (2013), 1 descendant of its own
- K233713: Pilling Tracheostomy Tubes (2024), 0 descendants of its own
- K172720: TRACOE silcosoft Tracheostomy Tube (2018), 0 descendants of its own

## Recalls of this device
- Aug 22, 2023 · Class II · Z-0205-2024: The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
- Aug 28, 2020 · Class II · Z-2946-2020: Label has the incorrect size for the tracheotomy tube.
- Feb 9, 2017 · Class II · Z-1465-2017: Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.

## Indications for use
The Bivona® Tracheostomy Tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single-patient use up to 10 times for adults sizes and up to 5 times for pediatric sizes.

Source page: https://510kreport.com/device/K083641
Methodology: https://510kreport.com/methodology