510(k) · Decided
DecidedAero Tracheobronchial Stent Technology 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 Nov 20, 2008 as substantially equivalent to K062511 (Alveolus, Inc., 2007) and 3 other predicates after a 101-day review. Its family tree reaches back 5 generations to 2001. 11 later devices descend from it.
- Decided
- Nov 20, 2008
- Review
- 101 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K003173 (2001). 10 ancestors in all, the oldest K894380 (1989). 11 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 4 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 3 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 2 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 1 generation backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- This deviceK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- Descendant · 2 generations on · 2 of its ownK130004 Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013
- Descendant · 3 generations on · 1 of its ownK233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · Recalled
- Descendant · cites it directly · 1 of its ownK202204 Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083625Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009 · cites it directly6descendants
- K121048Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012 · cites it directly5descendants
- K130004Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 2013 · 2 generations on2descendants
- K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 2024 · 3 generations on1descendant
- K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −4 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −3 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −2 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −1 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| 0 (this device) | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| +1 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| +1 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| +2 | K130004 | Ultraflex Esophageal NG Stent System | Boston Scientific Corporation | 2013 | — |
| +3 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024 | 22 |
| +1 | K202204 | Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XXSummary page 1…roduct code: JCT 21 CFR 878.3720 - Class II 15.2 Predicate Devices Alveolus, Inc. TB-STSTM Tracheobronchial Stent Technology System [510(k) Numbers K062511] Boston Scientific Corp. Inc. UltraflexTM Tracheobronchial Stent Technology System [501(k) Number K963241] Rusch International… | 2007 |
| * | K963241 | UltraflexSummary page 1…STSTM Tracheobronchial Stent Technology System [510(k) Numbers K062511] Boston Scientific Corp. Inc. UltraflexTM Tracheobronchial Stent Technology System [501(k) Number K963241] Rusch International Polyflex Stent Kit [510(k) Number K013266] 15.3 Description The Alveolus AEROTM is compris… | 1996 |
| * | K013266 | Rusch Polyflex Stent KitSummary page 1…062511] Boston Scientific Corp. Inc. UltraflexTM Tracheobronchial Stent Technology System [501(k) Number K963241] Rusch International Polyflex Stent Kit [510(k) Number K013266] 15.3 Description The Alveolus AEROTM is comprised of two components: the radiopaque stent and the delivery syst… | 2001 |
| * | K971509 | EndoxaneSummary page 2…Stent Technology System [501(k) Number K963241], the Rusch International Polyflex Stent Kit [510(k) Number K013266] and the Novatech S.A. Endoxane® Stent [510(k) Number K971509]. The single-patient-use components of the AEROTM Tracheobronchial Stent Technology System are provided non-sterile. 15.6 Conclu… | 1997 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K083625 (Alveolus, Inc., 2009) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K062511.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 AEROTM Tracheobronchial Stent Technology System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082284: Aero Tracheobronchial Stent Technology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082284
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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