510(k) · Cleared
Recalled · 2010Shiley Single Cannula Tracheostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shiley, Inc. · BTO Tube, Tracheostomy (W/Wo Connector)
Cleared on Feb 2, 1981 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 14 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 2, 1981
- Review
- 17 days
- Class
- Class II
- Product code
- BTO
- Recalls
- 6
- Predicates
- 0
13 later devices descend from it, 5 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- This deviceK810106 Shiley Single Cannula Tracheostomy TubeShiley, Inc. · 1981
- Descendant · cites it directly · 7 of its ownK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
- Descendant · cites it directly · 5 of its ownK963732 Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low…Mallinckrodt Medical · 1997 · Recalled
- Descendant · 2 generations on · 3 of its ownK142296 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner…Covidien · 2015 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK961449 Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996
- Descendant · 2 generations on · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · cites it directly7descendants
- K963732Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…Mallinckrodt Medical · 1997 · cites it directly5descendants
- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Covidien · 2015 · 2 generations on3descendants
- K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH · 1996 · cites it directly3descendants
- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810106 | Shiley Single Cannula Tracheostomy Tube | Shiley, Inc. | 1981 | — |
| +1 | K962173 | Shikey Tracheostomy Tubes and Accessories | Mallinckrodt Medical | 1996 | Class I |
| +1 | K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff… | Mallinckrodt Medical | 1997 | 2 |
| +2 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula… | Covidien | 2015 | Class I |
| +1 | K961449 | Tracheostomy Tubes Tracoe-Flex | Tracoe Medical GmbH | 1996 | — |
| +2 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 1 |
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 2 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
3 devices in this family have 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? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962173 | Shikey Tracheostomy Tubes and Accessories Class I | 1996 | 7 |
| K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and… | 1997 | 5 |
| K961449 | Tracheostomy Tubes Tracoe-Flex | 1996 | 3 |
| K030787 | Shiley Flextra Tracheostomy Tube | 2003 | 0 |
| K971267 | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension… | 1997 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2010 | Not classified | Z-1484-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1483-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1485-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1482-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1486-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1487-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Cites it directly · ◆ in the 1996 descendants bar of FIG. 11 Class I recall
- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible…Covidien · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy…Covidien · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K962173 (Mallinckrodt Medical, 1996) has gone furthest, with 7 descendants 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
2026 to Oct 25, outlined.
Median 510(k) review, days · BTO
98in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTO
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BTO
233in 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/K810106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K810106: Shiley Single Cannula Tracheostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K810106
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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