510(k) · Cleared
ClearedWalstent Tracheobronchial Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · JCT Prosthesis, Tracheal, Expandable
Cleared on Jul 10, 1996 as substantially equivalent to K934116 (Boston Scientific Scimed, Inc., 1994) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jul 10, 1996
- Review
- 82 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923119 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 1 generation backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- This deviceK961507 Walstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −1 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| 0 (this device) | K961507 | Walstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K934116 | Wallstent Tracheobronchial Prosthesis ModificationSummary page 4…s Regulation Number: 878.3720 Product Code: JCT Classification: Class Il 3. Predicate Device: Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K934116 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494 4. Device Description: The Wallstent Tracheobron… | 1994 |
| * | K945494 | Wallstent (R) Tracheobronchial EndoprosthesisSummary page 4…Predicate Device: Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K934116 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494 4. Device Description: The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical s… | 1995 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 5 other devices also cite its predicate K934116.
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 Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures and fistulas 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/K961507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961507: Walstent Tracheobronchial Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961507
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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