510(k) · Cleared
Recalled · Class II · 2016Ultraflex Tracheobronchial Covered 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 Oct 16, 2014 as substantially equivalent to K121048 (Boston Scientific Corp, 2012) and 2 other predicates after a 125-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 16, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- JCT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K003173 (2001). 31 ancestors in all, the oldest K894380 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK003173 Aspire Covered Stent and Delivery CatheterVascular Architects, Inc. · 2001
- 7 generations backK012544 Vascular Architects Aspire Covered Stent and Controlled Expansion…Vascular Architects, Inc. · 2001
- 6 generations backK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- 5 generations backK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- 4 generations backK062511 Aero Tracheobronchial Stent System, Model 90129-2XXAlveolus, Inc. · 2007
- 3 generations backK082284 Aero Tracheobronchial Stent Technology SystemAlveolus, Inc. · 2008
- 2 generations backK083625 Aero DV Tracheobronchial Stent SystemAlveolus, Inc. · 2009
- 1 generation backK121048 Ultraflex Tracheobronchial Stent System- Sterile UncoveredBoston Scientific Corp · 2012
- This deviceK141584 Ultraflex Tracheobronchial Covered Stent SystemBoston Scientific Corporation · 2014
- Descendant · cites it directly · 0 of its ownK230269 Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003173 | Aspire Covered Stent and Delivery Catheter | Vascular Architects, Inc. | 2001 | — |
| −7 | K012544 | Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery… | Vascular Architects, Inc. | 2001 | — |
| −6 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| −5 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| −4 | K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | Alveolus, Inc. | 2007 | — |
| −3 | K082284 | Aero Tracheobronchial Stent Technology System | Alveolus, Inc. | 2008 | — |
| −2 | K083625 | Aero DV Tracheobronchial Stent System | Alveolus, Inc. | 2009 | — |
| −1 | K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K141584 | Ultraflex Tracheobronchial Covered Stent System | Boston Scientific Corporation | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K121048 | Ultraflex Tracheobronchial Stent System- Sterile UncoveredSummary page 4…edicate Device: Trade Name: Ultraflex™ Tracheobronchial Uncovered Stent System Manufacturer and Clearance Number: Boston Scientific Corporation, K121048 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT C… | 2012 |
| * | K082284 | Aero Tracheobronchial Stent Technology SystemSummary page 4…Class II Trade Name: Aero Tracheobronchial Stent Technology System Manufacturer and Clearance Number:Alveolus Inc. (Merit Medical Endotek), K082284 Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT C… | 2008 |
| * | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Summary page 5…raflex Tracheobronchial Partially Covered Stent System is identical to the silicone cover material used on the Wallflex Esophageal Fully Covered Stent System cleared per K091510. With the exception of the silicone cover, the proposed UltraflexTM Tracheobronchial Partially Covered Stent System is identical… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230269 | Ultraflex™ Tracheobronchial Stent System | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2016 | Class II | Z-1567-2016 | Process control | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 31 ancestors have a recall of any class.
- Of its descendants, K230269 (Boston Scientific Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121048.
How does its category compare?
All JCT devicesJCT Prosthesis, Tracheal, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K141584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141584: Ultraflex Tracheobronchial Covered 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/K141584
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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