# K912469: Bivona Wire Reinforced Pediatric Tracheostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Bivona Medical Technologies
- Decided: Jun 19, 1991 after 15 days
- Product code: BTO (Tube, Tracheostomy (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: 44 (28 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031553: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes (2003), 1 descendant of its own
- K170720: Portex Blue Line Ultra Paediatric Tracheosomy Tube (2017), 0 descendants of its own
- K100480: Rota-Trach Tracheostomy Tube Model Rota-Trach (2010), 0 descendants of its own

## Recalls of this device
- May 29, 2024 · Class I · Z-2613-2024: 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.
- May 29, 2024 · Class I · Z-2612-2024: 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.
- May 29, 2024 · Class I · Z-2591-2024: 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.
- May 29, 2024 · Class I · Z-2610-2024: 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.
- May 29, 2024 · Class I · Z-2611-2024: 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.
- May 29, 2024 · Class I · Z-2607-2024: 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.
- May 29, 2024 · Class I · Z-2596-2024: 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.
- May 29, 2024 · Class I · Z-2606-2024: 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.
- May 29, 2024 · Class I · Z-2605-2024: 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.
- May 29, 2024 · Class I · Z-2599-2024: 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.
- May 29, 2024 · Class I · Z-2592-2024: 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.
- May 29, 2024 · Class I · Z-2598-2024: 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.
- May 29, 2024 · Class I · Z-2604-2024: 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.
- May 29, 2024 · Class I · Z-2595-2024: 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.
- May 29, 2024 · Class I · Z-2609-2024: 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.
- May 29, 2024 · Class I · Z-2593-2024: 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.
- May 29, 2024 · Class I · Z-2589-2024: 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.
- May 29, 2024 · Class I · Z-2602-2024: 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.
- May 29, 2024 · Class I · Z-2590-2024: 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.
- May 29, 2024 · Class I · Z-2597-2024: 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.
- May 29, 2024 · Class I · Z-2608-2024: 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.
- May 29, 2024 · Class I · Z-2588-2024: 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.
- May 29, 2024 · Class I · Z-2615-2024: 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.
- May 29, 2024 · Class I · Z-2614-2024: 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.
- May 29, 2024 · Class I · Z-2601-2024: 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.
- May 29, 2024 · Class I · Z-2600-2024: 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.
- May 29, 2024 · Class I · Z-2594-2024: 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.
- May 29, 2024 · Class I · Z-2603-2024: 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.
- Nov 28, 2011 · Not classified · Z-0659-2012: 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
- Nov 28, 2011 · Not classified · Z-0660-2012: 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
- Nov 28, 2011 · Not classified · Z-0661-2012: 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
- Nov 28, 2011 · Not classified · Z-0662-2012: 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
- Nov 28, 2011 · Not classified · Z-0663-2012: 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
- Nov 28, 2011 · Not classified · Z-0664-2012: 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
- Nov 28, 2011 · Not classified · Z-0665-2012: 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
- Nov 28, 2011 · Not classified · Z-0669-2012: 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
- Nov 28, 2011 · Not classified · Z-0656-2012: 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
- Nov 28, 2011 · Not classified · Z-0657-2012: 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
- Nov 28, 2011 · Not classified · Z-0658-2012: 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
- Nov 28, 2011 · Not classified · Z-0666-2012: 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
- Nov 28, 2011 · Not classified · Z-0667-2012: 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
- Nov 28, 2011 · Not classified · Z-0668-2012: 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
- Nov 28, 2011 · Not classified · Z-0671-2012: 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
- Nov 28, 2011 · Not classified · Z-0670-2012: 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

Source page: https://510kreport.com/device/K912469
Methodology: https://510kreport.com/methodology