510(k) · Cleared
ClearedUltraflex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · JCT Prosthesis, Tracheal, Expandable
Cleared on Nov 14, 1996 after an 87-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 9 citing it directly.
- This deviceK963241 UltraflexBoston Scientific Corp · 1996
- Descendant · cites it directly · 21 of its ownK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- Descendant · cites it directly · 18 of its ownK030947 Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003
- Descendant · 2 generations on · 15 of its ownK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- Descendant · cites it directly · 15 of its ownK033990 Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
- Descendant · cites it directly · 15 of its ownK033053 Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…Boston Scientific Corp · 2001 · cites it directly21descendants
- K030947Alveolus Inc., TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2003 · cites it directly18descendants
- K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008 · 2 generations on15descendants
- K033990Alveolus Inc. TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · cites it directly15descendants
- K033053Alveolus, TB-STS Tracheobronchial Stent SystemAlveolus, Inc. · 2004 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963241 | Ultraflex | Boston Scientific Corp | 1996 | — |
| +1 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| +1 | K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2003 | — |
| +2 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| +1 | K033990 | Alveolus Inc. TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
| +1 | K033053 | Alveolus, TB-STS Tracheobronchial Stent System | Alveolus, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | Wallstent Tracheobronchial Stent System Named without a submission number | |
| * | — | Wallstent Tracheobronchial Endoprosthesis Named without a submission number |
What descends from it? (35)
See all 359 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex… | 2001 | 21 |
| K030947 | Alveolus Inc., TB-STS Tracheobronchial Stent System | 2003 | 18 |
| K033990 | Alveolus Inc. TB-STS Tracheobronchial Stent System | 2004 | 15 |
| K033053 | Alveolus, TB-STS Tracheobronchial Stent System | 2004 | 15 |
| K062511 | Aero Tracheobronchial Stent System, Model 90129-2XX | 2007 | 14 |
| K082284 | Aero Tracheobronchial Stent Technology System | 2008 | 11 |
| K121048 | Ultraflex Tracheobronchial Stent System- Sterile Uncovered | 2012 | 5 |
| K990221 | Intracoil Peripheral Stent | 1999 | 1 |
| K032744 | Alveolus Inc., TB-STS Tracheobronchial Stent System | 2003 | 0 |
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?
- Of its descendants, K012883 (Boston Scientific Corp, 2001) has gone furthest, with 21 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.
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 indicated for 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/K963241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963241: Ultraflex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963241
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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