510(k) · Cleared
Recalled · Class I · 2015Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · JOH Tube Tracheostomy And Tube Cuff
Cleared on Feb 13, 2015 as substantially equivalent to K955680 (Mallinckrodt Medical, 1996) and 2 other predicates after a 179-day review. Its family tree reaches back 3 generations to 2008. 2 of the 6 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Feb 13, 2015
- Review
- 179 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K081440 (2008). 5 ancestors in all, the oldest K945513 (1995). No later device cites it as a predicate yet. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK081440 Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy TubesSmiths Medical Asd, Inc. · 2008 · Recalled
- 2 generations backK083641 Bivona Tracheostomy TubesSmiths Medical Asd, Inc. · 2009 · Recalled
- 1 generation backK122531 Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · Recalled (Class I)
- This deviceK142298 Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with…Covidien · 2015
Class I recalls in this family
- K122531 Shiley Neonatal Tracheostomy Tube Cuffless…direct predicate · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K081440 | Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2008 | 1 |
| −2 | K083641 | Bivona Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2009 | 3 |
| −1 | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube… | Covidien | 2012 | Class I |
| 0 (this device) | K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard… | Covidien | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955680 | Shiley Cuffed Pediatric Tracheostomy Tube; Long CuffedSummary page 4…CFR 868.5800 – Class II Device Product Code & Panel: JOH Predicate Devices: Shiley™ Cuffed Pediatric & Pediatric Long (K955680) Shiley™ Neonatal, Pediatric & Pediatric Long… | 1996 |
| * | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…Summary page 4…Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes Cuffless (K122531) Smiths Medical Bivona Aire-Cuf Tracheostomy Tubes… | 2012 |
| * | K083641 | Bivona Tracheostomy TubesSummary page 4…es Cuffless (K122531) Smiths Medical Bivona Aire-Cuf Tracheostomy Tubes (K083641) Device Description The subject devices are single use; single cannula tracheostomy tubes that are intended to provide an artifi… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2015 | Class I | Z-1950-2015 | Device Design | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen… |
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.
- K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
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. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Shiley™ Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff are intended for use in providing tracheal access for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142298: Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026