510(k) · Cleared
Recalled · 2010Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula
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 Jun 26, 1997 as substantially equivalent to K811447 (Shiley, Inc., 1981) and 1 other predicate after a 282-day review. Its family tree reaches back 1 generation to 1981. 2 of the 8 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 26, 1997
- Review
- 282 days
- Class
- Class II
- Product code
- JOH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810106 (1981). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK810106 Shiley Single Cannula Tracheostomy TubeShiley, Inc. · 1981 · Recalled
- This deviceK963732 Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low…Mallinckrodt Medical · 1997
- Descendant · cites it directly · 3 of its ownK142296 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner…Covidien · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK150844 Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner…Covidien · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK251313 Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff…Covidien, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK193077 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
- Descendant · cites it directly · 0 of its ownK030787 Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. · 2003 · Recalled
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Covidien · 2015 · cites it directly3descendants
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Covidien · 2015 · 2 generations on1descendant
- K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…Covidien, LLC · 2025 · 2 generations on0descendants
- K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020 · 3 generations on0descendants
- K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810106 | Shiley Single Cannula Tracheostomy Tube | Shiley, Inc. | 1981 | 6 |
| 0 (this device) | K963732 | Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff… | Mallinckrodt Medical | 1997 | — |
| +1 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula… | Covidien | 2015 | Class I |
| +2 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula… | Covidien | 2015 | Class I |
| +2 | K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal… | Covidien, LLC | 2025 | — |
| +3 | K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | Covidien | 2020 | — |
| +1 | K030787 | Shiley Flextra Tracheostomy Tube | Nellcor Puritan Bennett, Inc. | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 2 | 2 |
| 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.
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 |
|---|---|---|---|
| * | K811447 | Shiley Disposable Cannula Trach. TubeSummary page 1…(3) Substantially Equivalent Devices Registration numbers: » Shiley DCT Dual Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula- 510(k) No. K811447. « Shiley Cuffed Single Cannula SCT Tracheostomy Tubes - 510(k) No. K810106. (4) Intended Use: The device is used to provide an… | 1981 |
| * | K810106 | Shiley Single Cannula Tracheostomy TubeSummary page 1…ual Cannula Tracheostomy Tube with Low Pressure Cuff and Disposable Inner Cannula- 510(k) No. K811447. « Shiley Cuffed Single Cannula SCT Tracheostomy Tubes - 510(k) No. K810106. (4) Intended Use: The device is used to provide an artificial airway in order to assist in the treatment of a variety of respir… | 1981 |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Apr 13, 2010 | Not classified | Z-1475-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
| Apr 13, 2010 | Not classified | Z-1474-2010 | Process design | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. |
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 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy…Covidien · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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 | — |
What is it indicated for?
1. This device-is osed-to-orovide*an-artificial-airway ir-order-to-assist in the treatment of a variety of respiratory diseases and airway management for adult patients.
2. The device is to be used by the order of a nhysician.
3. The device is primarily intended for use in conjunction with Percutaneous Dilational (or Dilatational) Tracheotomy and is inserted into the natient using the Introducer orovided with the Percutaneous Dilational Kit.
4. The device is intended to be used as the initial artificial airway immediately post tracheotomy.
5. There is no "new" intended theraneutic use of this device to existing devices marketed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963732 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963732: Percutaneous Dual Cannula Tracheostomy Tube with Low Pressure/Low Profile Cuff and Disposable Inner Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963732
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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