510(k) · Cleared
ClearedUltraflex™ Tracheobronchial Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · JCT Prosthesis, Tracheal, Expandable
Cleared on Jul 14, 2023 as substantially equivalent to K141584 (Boston Scientific Corporation, 2014) and 1 other predicate after a 164-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Jul 14, 2023
- Review
- 164 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K003173 (2001). 32 ancestors in all, the oldest K894380 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 5 generations between
- 3 generations backK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- 2 generations backK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- 1 generation backK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · Recalled
- This deviceK230269 Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023
Show all 9 generations
- Root · 9 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 8 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 7 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 6 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 5 generations backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- 4 generations backK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- 3 generations backK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- 2 generations backK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- 1 generation backK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014 · Recalled
- This deviceK230269 Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −8 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −7 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −6 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −5 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| −4 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| −3 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| −2 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| −1 | K141584 | Ultraflex Tracheobronchial Covered Stent System | Boston Scientific Corporation | 2014 | 1 |
| 0 (this device) | K230269 | Ultraflex™ Tracheobronchial Stent System | Boston Scientific Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 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 K202204 Tracheal Stent Systemscore 6.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K141584 | Ultraflex Tracheobronchial Covered Stent SystemSummary page 4…ulation: 21 CFR 878.3720 3. Predicate Devices Trade Name: Ultraflex™ Tracheobronchial Partially Covered Stent System Clearance Number: K141584 Common Name: Tracheal Prosthesis Product Code: JCT Device Class and Panel: Class II, Gener… | 2014 |
| * | K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredSummary page 4…tic Surgery Classification Regulation: 21 CFR 878.3720 Trade Name: Ultraflex™ Tracheobronchial Uncovered Stent System Clearance Number: K121048 Common Name: Tracheal Prosthesis Product Code: JCT Device Class and Panel: Class II, Gener… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 32 ancestors have a recall of any class.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
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/K230269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230269: Ultraflex™ Tracheobronchial Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230269
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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