510(k) · Cleared
ClearedDumon Tracheobronchial Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bryan Corp. · NWA Prosthesis, Tracheal, Preformed/Molded
Cleared on Oct 24, 1989 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.
- Decided
- Oct 24, 1989
- Review
- 99 days
- Class
- Class II
- Product code
- NWA
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 1 citing it directly.
- This deviceK894380 Dumon Tracheobronchial StentBryan Corp. · 1989
- Descendant · cites it directly · 21 of its ownK971509 EndoxaneNovatech SA · 1997
- Descendant · 2 generations on · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K971509EndoxaneNovatech SA · 1997 · cites it directly21descendants
- K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · 2 generations on15descendants
- K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007 · 2 generations on14descendants
- K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · 2 generations on11descendants
- K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894380 | Dumon Tracheobronchial Stent | Bryan Corp. | 1989 | — |
| +1 | K971509 | Endoxane | Novatech SA | 1997 | — |
| +2 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| +2 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| +2 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| +3 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NWA? 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 NWA device
- #1 K261541 VisionAir Enhanced Stock Stentscore 12.0 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971509 | Endoxane | 1997 | 21 |
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, K971509 (Novatech SA, 1997) has gone furthest, with 21 descendants of its own.
How does its category compare?
All NWA devicesNWA Prosthesis, Tracheal, Preformed/Molded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NWA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NWA
Too few NWA 510(k)s in any year since 2007 to give a median.
Recalls per year · NWA
No recall names NWA since 2007.
Adverse event reports per year · NWA
2in 2021
MAUDE reports naming product code NWA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K894380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894380: Dumon Tracheobronchial Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894380
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026