510(k) · Cleared
Recalled · 2010Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · JOH Tube Tracheostomy And Tube Cuff
Cleared on Mar 13, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Mar 13, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 8
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK955680 Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedMallinckrodt Medical · 1996
- Descendant · cites it directly · 0 of its ownK142298 Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with…Covidien · 2015 · Recalled (Class I)
Class I recalls in this family
- K142298 Shiley Neonatal, Pediatric & Pediatric Long…cites it directly · 2015
Most influential descendants
Showing 1 of 1 · See all- K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed | Mallinckrodt Medical | 1996 | — |
| +1 | K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard… | Covidien | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
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 JOH device
- #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff Class I | 2015 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2010 | Not classified | Z-1497-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1493-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1499-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1498-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1492-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1496-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1494-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1495-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
The 5 latest of 8 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.
- K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K142298 (Covidien, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOH devicesJOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOH
137in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOH
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · JOH
986in 2025
MAUDE reports naming product code JOH, 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 | — | 1 | 167 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 1 | 195 |
| 2010 | 2 | — | 73 | 1,270 |
| 2011 | 0 | — | 4 | 587 |
| 2012 | 1 | — | 0 | 500 |
| 2013 | 3 | 407 | 0 | 544 |
| 2014 | 3 | 218 | 0 | 506 |
| 2015 | 3 | 179 | 0 | 508 |
| 2016 | 1 | — | 2 (1) | 572 |
| 2017 | 1 | — | 0 | 441 |
| 2018 | 3 | 137 | 0 | 812 |
| 2019 | 2 | — | 0 | 1,019 |
| 2020 | 1 | — | 1 | 791 |
| 2021 | 2 | — | 0 | 1,041 |
| 2022 | 0 | — | 0 | 1,632 |
| 2023 | 0 | — | 1 | 1,233 |
| 2024 | 0 | — | 0 | 1,103 |
| 2025 | 1 | — | 0 | 986 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K955680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955680: Shiley Cuffed Pediatric Tracheostomy Tube; Long Cuffed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955680
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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