510(k) · Cleared
ClearedEndoxane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novatech SA · NWA Prosthesis, Tracheal, Preformed/Molded
Cleared on Aug 21, 1997 as substantially equivalent to K894380 (Bryan Corp., 1989) after a 118-day review. Its family tree reaches back 1 generation to 1989. 21 later devices descend from it.
- Decided
- Aug 21, 1997
- Review
- 118 days
- Class
- Class II
- Product code
- NWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894380 (1989). 21 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK894380 Dumon Tracheobronchial StentBryan Corp. · 1989
- This deviceK971509 EndoxaneNovatech SA · 1997
- Descendant · cites it directly · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · cites it directly15descendants
- K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007 · cites it directly14descendants
- K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · cites it directly11descendants
- K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · 2 generations on6descendants
- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894380 | Dumon Tracheobronchial Stent | Bryan Corp. | 1989 | — |
| 0 (this device) | K971509 | Endoxane | Novatech SA | 1997 | — |
| +1 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| +1 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| +1 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| +2 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| +2 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (1)
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 |
|---|---|---|---|
| * | K894380 | Dumon Tracheobronchial StentSummary page 5…evice that we have cited for comparison is the ENDOXANE ® Stent, the same as ours, which was sold by our sole United States distributor, the Bryan Corporation (510K # K 4894380). The device description can be found in Section IV Description of Device. In short, the ENDOXANE® is an endoscopy stent made of… | 1989 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033053 | Alveolus, TB-STS Tracheobronchial Stent System | 2004 | 15 |
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | 2007 | 14 |
| K082284 | Aero Tracheobronchial Stent Technology System | 2008 | 11 |
| K182743 | Patient-Specific Airway Stent | 2019 | 2 |
| K243126 | Tracheobronxane™ Dumon® | 2024 | 0 |
| K212403 | Tracheal Stent System (Y-Shaped) | 2021 | 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?
- Its one ancestor has no recall.
- Of its descendants, K033053 (Alveolus, Inc., 2004) has gone furthest, with 15 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 | — |
What is it indicated for?
The main indications according to their frequency are : 1. tracheobronchial tumors 2. Tracheal stenosis with scarring 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or…
Read the full statement (112 words)
The main indications according to their frequency are :
1. tracheobronchial tumors
2. Tracheal stenosis with scarring
3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation.
These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion indication is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen of the airway is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.
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/K971509 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971509: Endoxane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971509
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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