510(k) · Cleared
Recalled · Class I · 2025Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable 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 Jul 14, 2015 as substantially equivalent to K142296 (Covidien, 2015) and 1 other predicate after a 106-day review. Its family tree reaches back 3 generations to 1979. 3 of the 15 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jul 14, 2015
- Review
- 106 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 2 (2 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K792222 (1979). 13 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK792222 Shiley Low Pressure Thin-Cuffed Trach.Shiley, Inc. · 1979
- 2 generations backK962173 Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Recalled (Class I)
- 1 generation backK142296 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner…Covidien · 2015 · Recalled (Class I)
- This deviceK150844 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner…Covidien · 2015
- Descendant · cites it directly · 0 of its ownK193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792222 | Shiley Low Pressure Thin-Cuffed Trach. | Shiley, Inc. | 1979 | — |
| −2 | K962173 | Shikey Tracheostomy Tubes and Accessories | Mallinckrodt Medical | 1996 | Class I |
| −1 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula… | Covidien | 2015 | Class I |
| 0 (this device) | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula… | Covidien | 2015 | — |
| +1 | 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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Summary page 4…JOH Predicate Devices: Shiley™ Adult Flexible Tracheostomy Tube, Disposable Inner Cannula (K142296) Shiley™ Tracheostomy Tubes (K962173) Device Description The subject devices are… | 2015 |
| * | K962173 | Shikey Tracheostomy Tubes and AccessoriesSummary page 4…tomy Tube, Disposable Inner Cannula (K142296) Shiley™ Tracheostomy Tubes (K962173) Device Description The subject devices are single patient-use dual cannula tracheostomy tubes that are intended to provide an a… | 1996 |
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 |
|---|---|---|---|
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | 2020 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2025 | Class I | Z-1390-2025 | Under Investigation by firm | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract… |
| 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.
- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible…Covidien · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical · 1996 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 6 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K193077 (Covidien, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142296.
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™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is intended to provide
tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is intended to provide tracheal access
for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube with TaperGuard™ Cuff, Reusable Inner Cannula is also intended for
use with Percutaneous Dilatational Tracheotomy (PDT) procedures.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula is also intended for use with
Percutaneous Dilatational Tracheotomy (PDT) procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150844: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150844
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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