510(k) · Cleared
ClearedFenestrated Flexible D.I.C. Tracheostomy Tube Cuffed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · JOH Tube Tracheostomy And Tube Cuff
Cleared on Jan 20, 1998 after a 208-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 20, 1998
- Review
- 208 days
- Class
- Class II
- Product code
- JOH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972385 Fenestrated Flexible D.I.C. Tracheostomy Tube CuffedSmiths Industries Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK062104 Talking TrachEngineered Medical Systems, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062104Talking TrachEngineered Medical Systems, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972385 | Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed | Smiths Industries Medical Systems, Inc. | 1998 | — |
| +1 | K062104 | Talking Trach | Engineered Medical Systems, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
Planning a device in JOH? 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? (5)
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 |
|---|---|---|---|
| * | — | Flexible D.I.C. Tracheostomy Tube Named without a submission number | |
| * | — | Fenestrated Blue Line Tracheostomy Tube Named without a submission number | |
| * | — | Fenestrated D.I.C. Tracheostomy Tube Named without a submission number | |
| * | — | Shiley’s fenestrated low pressure cuffed tracheostomy tube Named without a submission number | |
| * | — | Boston Medical Products’ Tracoe fenestrated tracheostomy tube Named without a submission number |
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 |
|---|---|---|---|
| K062104 | Talking Trach | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062104 (Engineered Medical Systems, Inc., 2007) has gone furthest, with 0 descendants of its own.
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?
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
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/K972385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972385: Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972385
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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