510(k) · Cleared
Recalled · Class I · 2023Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
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 24, 2015 as substantially equivalent to K962173 (Mallinckrodt Medical, 1996) and 1 other predicate after a 190-day review. Its family tree reaches back 2 generations to 1979. 3 of the 16 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Feb 24, 2015
- Review
- 190 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K792222 (1979). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
- 1 generation backK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
- This deviceK142296 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner…Covidien · 2015
- Descendant · cites it directly · 1 of its ownK150844 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner…Covidien · 2015 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK251313 Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff…Covidien, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Covidien · 2015 · cites it directly1descendant
- K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…Covidien, LLC · 2025 · cites it directly0descendants
- K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792222 | Shiley Low Pressure Thin-Cuffed Trach. | Shiley, Inc. | 1979 | — |
| −1 | K962173 | Shikey Tracheostomy Tubes and Accessories | Mallinckrodt Medical | 1996 | Class I |
| 0 (this device) | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula… | Covidien | 2015 | — |
| +1 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula… | Covidien | 2015 | Class I |
| +1 | K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal… | Covidien, LLC | 2025 | — |
| +2 | K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 4 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 1 |
| 2020 | 1 | 0 |
| 2025 | 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.
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 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 |
|---|---|---|---|
| * | K962173 | Shikey Tracheostomy Tubes and AccessoriesSummary page 5…istribution: Trade Name: Shiley™ Tracheostomy Tubes Device Common Name: Tube Tracheostomy and Tube Cuff 510(k) Number: K962173 Manufacturer: Covidien, formerly Tyco Healthcare Trade Name: Shiley™ DCT Adult Cuffed Per… | 1996 |
| * | K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and…Summary page 5…Shiley™ DCT Adult Cuffed Percutaneous Tracheostomy Tubes Device Common Name: Tube Tracheostomy and Tube Cuff 510(k) Number: K963732 Manufacturer: Covidien, formerly Tyco Healthcare Intended Use The device is intended to be used to pro… | 1997 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2023 | Class I | Z-1357-2023 | Component change control | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure… |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy…Covidien · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 18.4 years on median.
- 5 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150844 (Covidien, 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K962173.
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?
Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is intended for use in providing tracheal access for airway management.
Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Disposable Inner Cannula is also intended for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Disposable Inner Cannula is intended to be used with the appropriate Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff or Cuffless to provide tracheal access for airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142296: Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142296
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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