510(k) · Decided
DecidedAero DV 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 Mar 11, 2009 as substantially equivalent to K071604 (Alveolus, Inc., 2007) and 2 other predicates after a 93-day review. Its family tree reaches back 6 generations to 2001. 6 later devices descend from it.
- Decided
- Mar 11, 2009
- Review
- 93 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K003173 (2001). 12 ancestors in all, the oldest K894380 (1989). 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 5 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 4 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 3 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 2 generations backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- 1 generation backK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- This deviceK083625 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 · 2 generations on · 1 of its ownK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K141584Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · 2 generations on1descendant
- K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −5 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −4 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −3 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −2 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| −1 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| 0 (this device) | 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 |
| +2 | K141584 | Ultraflex Tracheobronchial Covered Stent System | Boston Scientific Corporation | 2014 | 1 |
| +4 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent… | Boston Scientific Corporation | 2026 | — |
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 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K071604 | Alveolus Aero DV Tracheobronchial Stent SystemSummary page 1…21 CFR 878.3720 - Class II Predicate Devices Alveolus AERO DVTm Tracheobronchial Stent System (510(k) Number: K071 604) Alveolus AERO Tm Tracheobronchial Stent System (510(k) Number: K082284) Rusch International (owned by Bost… | 2007 |
| * | K082284 | Aero Tracheobronchial Stent Technology SystemSummary page 1…Alveolus AERO DVTm Tracheobronchial Stent System (510(k) Number: K071 604) Alveolus AERO Tm Tracheobronchial Stent System (510(k) Number: K082284) Rusch International (owned by Boston Scientific) Polyflex Airway Stent (510(k) Number: K013266) D… | 2008 |
| * | K013266 | Rusch Polyflex Stent KitSummary page 1…ERO Tm Tracheobronchial Stent System (510(k) Number: K082284) Rusch International (owned by Boston Scientific) Polyflex Airway Stent (510(k) Number: K013266) Description CONFIDENTIAL Alveolus AERO DV' M Premarket Notification Page 42 of 44 ===… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | 2012 | 5 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K121048 (Boston Scientific Corp, 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 AERO DV™ Tracheobronchial Stent 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/K083625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083625: Aero DV Tracheobronchial Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083625
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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