510(k) · Cleared
Recalled · 2011Wallstent 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 Dec 4, 1996 as substantially equivalent to K934116 (Boston Scientific Scimed, Inc., 1994) and 2 other predicates after a 50-day review. Its family tree reaches back 3 generations to 1992. 44 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 1996
- Review
- 50 days
- Class
- Class II
- Product code
- JCT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K923119 (1992). 4 ancestors in all. 44 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 2 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 1 generation backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- This deviceK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996
- Descendant · cites it directly · 41 of its ownK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- Descendant · cites it directly · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · 2 generations on · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 3 generations on · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K980163Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis…Boston Scientific Scimed, Inc. · 1998 · cites it directly41descendants
- K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · cites it directly40descendants
- K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · 2 generations on37descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −2 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −1 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| 0 (this device) | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | — |
| +1 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| +1 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +2 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| +3 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +3 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K934116 | Wallstent Tracheobronchial Prosthesis ModificationSummary page 4…s Regulation Number: 878.3720 Product Code: JCT Classification: Class II 3. Predicate Device: Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K934116 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494 Boston Scientific Corporation’s Wallstent Tracheob… | 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 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K961296 4. Device Description: The Wallstent Tracheobron… | 1995 |
| * | K961296 | Wallstent Tracheobronchial EndoprosthesisSummary page 4…Prosthesis, K934116 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K961296 4. Device Description: The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical s… | 1996 |
| † | K940396 | Wallstent Esophageal Prosthesis (Double) | 1994 |
What descends from it? (44)
See all 443 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2011 | Not classified | Z-2832-2011 | Labeling False and Misleading | Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT"… |
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 1.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K980163 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 41 descendants of its own.
- 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 produced by malignant neoplasms.
The Wallstent Tracheobronchial Endoprosthesis with Permalume® Covering is intended for use in the treatment of tracheobronchial strictures or 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/K964121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964121: Wallstent Tracheobronchial Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964121
Report an extraction error
Are you the manufacturer?
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