510(k) · Cleared
Recalled · 2010Shiley Specialized,Pediatric & Neonatal Trach.Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedica, Fiat, USA, Inc. · CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Cleared on Mar 26, 1993 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 5 times.
- Decided
- Mar 26, 1993
- Review
- 140 days
- Class
- Class II
- Product code
- CBI
- Recalls
- 5
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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.
Planning a device in CBI? 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 CBI device
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What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2010 | Not classified | Z-1512-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1510-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1513-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1511-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1514-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CBI devicesCBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBI
134in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBI
83in 2025
MAUDE reports naming product code CBI, 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 | 0 | — | 0 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 1 | — | 0 | 26 |
| 2010 | 2 | — | 0 | 25 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 3 | 134 | 0 | 23 |
| 2013 | 1 | — | 0 | 26 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 2 | — | 0 | 66 |
| 2019 | 0 | — | 1 | 94 |
| 2020 | 1 | — | 0 | 87 |
| 2021 | 2 | — | 0 | 159 |
| 2022 | 1 | — | 0 | 127 |
| 2023 | 1 | — | 0 | 95 |
| 2024 | 1 | — | 1 | 75 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K925615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925615: Shiley Specialized,Pediatric & Neonatal Trach.Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925615
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026