510(k) · Cleared
ClearedAlveolus Inc. TB-STS Tracheobronchial Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alveolus, Inc. · JCT Prosthesis, Tracheal, Expandable
Cleared on May 12, 2004 as substantially equivalent to K030947 (Alveolus, Inc., 2003) and 3 other predicates after a 141-day review. Its family tree reaches back 3 generations to 2001. 15 later devices descend from it.
- Decided
- May 12, 2004
- Review
- 141 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003173 (2001). 4 ancestors in all, the oldest K963241 (1996). 15 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 2 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 1 generation backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- This deviceK033990 Alveolus Inc. 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 · 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
- Descendant · 3 generations on · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- Descendant · 4 generations on · 2 of its ownK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K062511Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007 · cites it directly14descendants
- K082284Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008 · 2 generations on11descendants
- K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · 3 generations on6descendants
- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · 3 generations on5descendants
- K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −2 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −1 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| 0 (this device) | K033990 | Alveolus Inc. TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| +4 | K130004 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 JCT? 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 JCT device
- #1 K230269 Ultraflex™ Tracheobronchial Stent Systemscore 8.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent SystemSummary page 4…tion TB-STS™ Tracheobronchial Stent System “Tracheal Prosthesis”, Product code: JCT Class Il Alveolus, Inc. TB-_S‘:I'STM Tracheobronchial Stent System [510(k) Numbers K030947] Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241] Vascular Architects, Inc. aSpire… | 2003 |
| * | K963241 | UltraflexSummary page 4…Alveolus, Inc. TB-_S‘:I'STM Tracheobronchial Stent System [510(k) Numbers K030947] Boston Scientific Corp. Inc. Ultraflex™ Tracheobronchial Stent System [501(k) Number K963241] Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544]… | 1996 |
| * | K003173 | Aspire Covered Stent and Delivery CatheterSummary page 4…ltraflex™ Tracheobronchial Stent System [501(k) Number K963241] Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544] The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the… | 2001 |
| * | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery SystemSummary page 4…acheobronchial Stent System [501(k) Number K963241] Vascular Architects, Inc. aSpire™ Covered Stent and CONTROLLED EXPANSION™ Delivery System [510(k) Number K003173 and K012544] The Alveolus Tracheobronchial Stent Technology System is comprised of two components: the radiopaque stent and the delivery sys… | 2001 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | 2007 | 14 |
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062511 (Alveolus, Inc., 2007) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K030947.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JCT
234in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCT
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCT
50in 2025
MAUDE reports naming product code JCT, 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 | 2 | — | 0 | 150 |
| 2008 | 1 | — | 0 | 143 |
| 2009 | 1 | — | 0 | 163 |
| 2010 | 0 | — | 46 | 147 |
| 2011 | 0 | — | 2 | 95 |
| 2012 | 1 | — | 0 | 109 |
| 2013 | 0 | — | 0 | 238 |
| 2014 | 3 | 234 | 0 | 168 |
| 2015 | 0 | — | 0 | 251 |
| 2016 | 1 | — | 0 | 217 |
| 2017 | 0 | — | 0 | 109 |
| 2018 | 1 | — | 0 | 122 |
| 2019 | 0 | — | 0 | 106 |
| 2020 | 1 | — | 0 | 120 |
| 2021 | 2 | — | 0 | 106 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 1 | — | 0 | 110 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 50 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alveolus TB-STS™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures and airway compression (stenosis) produced by malignant neoplasms. Because the device is removable it may also be used to treat conditions such as tracheo-esophageal fistula resulting from malignancies and strictures resulting from surgical anastomosis of the airway in patients with malignancies.
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/K033990 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033990: Alveolus Inc. TB-STS Tracheobronchial Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033990
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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