510(k) · Cleared
Recalled · Class I · 2015Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T
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 Oct 9, 2012 as substantially equivalent to K945513 (Mallinckrodt Medical, 1995) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 2008. 2 of the 6 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Oct 9, 2012
- Review
- 50 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081440 (2008). 3 ancestors in all, the oldest K945513 (1995). 2 later devices descend from it, 2 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK081440 Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy TubesSmiths Medical Asd, Inc. · 2008 · Recalled
- 1 generation backK083641 Bivona Tracheostomy TubesSmiths Medical Asd, Inc. · 2009 · Recalled
- This deviceK122531 Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric…Covidien · 2012
- Descendant · cites it directly · 0 of its ownK170720 Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc. · 2017
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081440 | Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2008 | 1 |
| −1 | K083641 | Bivona Tracheostomy Tubes | Smiths Medical Asd, Inc. | 2009 | 3 |
| 0 (this device) | K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube… | Covidien | 2012 | — |
| +1 | K170720 | Portex Blue Line Ultra Paediatric Tracheosomy Tube | Smiths Medical Asd, Inc. | 2017 | — |
| +1 | K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard… | Covidien | 2015 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K945513 | Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy TubeSummary page 1…Shiley Pediatric and Neonatal Tracheostomy Tubes Device Common Name: Tube Tracheostomy and Tube Cuff 510(k) Number: K945513 Manufacturer: Covidien, formerly Tyco Healthcare Trade Name:… | 1995 |
| * | K083641 | Bivona Tracheostomy TubesSummary page 2…Bivona Tracheostomy Tube Tracheostomy Tubes Device Common Name: Tube Tracheostomy and Tube Cuff 510(k) Number: K083641 Manufacturer: Smiths Medical ASID, Inc. Intended Use The device is intended to be used to provide… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1951-2015 | 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.
- 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K170720 (Smiths Medical Asd, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K945513.
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. 2012, 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?
This device is intended for use in providing tracheal access for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122531: Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122531
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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