510(k) · Cleared
Recalled · Class I · 2024Bivona Wire Reinforced Pediatric Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bivona Medical Technologies · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Jun 19, 1991 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 44 times, including 28 Class I recalls.
- Decided
- Jun 19, 1991
- Review
- 15 days
- Class
- Class II
- Product code
- BTO
- Recalls
- 44 (28 Class I)
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK912469 Bivona Wire Reinforced Pediatric Tracheostomy TubeBivona Medical Technologies · 1991
- Descendant · cites it directly · 1 of its ownK031553 Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal…Arcadia Medical Corporation · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK170720 Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK100480 Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation · 2010
Most influential descendants
Showing 3 of 3 · See all- K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric…Arcadia Medical Corporation · 2003 · cites it directly1descendant
- K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. · 2017 · cites it directly0descendants
- K100480Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912469 | Bivona Wire Reinforced Pediatric Tracheostomy Tube | Bivona Medical Technologies | 1991 | — |
| +1 | K031553 | Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and… | Arcadia Medical Corporation | 2003 | 2 |
| +1 | K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | 2017 | — |
| +2 | K100480 | Rota-Trach Tracheostomy Tube Model Rota-Trach | Vitaltec Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTO device
- #1 K242921 5300600-5301000 Rota-Trach Disposable Standard…score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2024 | Class I | Z-2613-2024 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0660-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0661-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0662-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0663-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0664-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0665-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0669-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0656-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0657-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0658-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0666-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0667-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0668-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0671-2012 | Device Design | 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… |
| Nov 28, 2011 | Not classified | Z-0670-2012 | Device Design | 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 5 latest of 44 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031553 (Arcadia Medical Corporation, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BTO devicesBTO Tube, Tracheostomy (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTO
1in 2025
2007high 3 (2010) · low 0 (2013)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
2007high 98 (2010)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
2007high 19 (2011) · low 0 (2007)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 2025
2007high 795 (2009) · low 54 (2011)2025
MAUDE reports naming product code BTO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 226 |
| 2008 | 1 | — | 0 | 255 |
| 2009 | 1 | — | 2 | 795 |
| 2010 | 3 | 98 | 6 | 130 |
| 2011 | 1 | — | 19 | 54 |
| 2012 | 1 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 78 |
| 2014 | 0 | — | 0 | 173 |
| 2015 | 0 | — | 1 | 172 |
| 2016 | 0 | — | 0 | 212 |
| 2017 | 0 | — | 0 | 126 |
| 2018 | 1 | — | 0 | 162 |
| 2019 | 0 | — | 0 | 87 |
| 2020 | 1 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 198 |
| 2022 | 0 | — | 0 | 770 |
| 2023 | 0 | — | 1 (1) | 402 |
| 2024 | 1 | — | 0 | 418 |
| 2025 | 1 | — | 0 | 233 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K912469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K912469: Bivona Wire Reinforced Pediatric Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912469
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026