510(k) · Cleared
Recalled · Class II · 2018Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis Tracheobronchial
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 May 19, 2016 as substantially equivalent to K992510 (Boston Scientific Corp, 1999) after a 233-day review. Its family tree reaches back 5 generations to 1992. It has been recalled 5 times.
- Decided
- May 19, 2016
- Review
- 233 days
- Class
- Class II
- Product code
- JCT
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923119 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 4 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 3 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 2 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 1 generation backK992510 Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery…Boston Scientific Corp · 1999 · Recalled
- This deviceK152842 Wallstent RP Endoprosthesis Tracheobronchial, Wallstent…Boston Scientific Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −4 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −3 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −2 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −1 | K992510 | Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Corp | 1999 | 1 |
| 0 (this device) | K152842 | Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis… | Boston Scientific Corporation | 2016 | — |
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? (1)
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 |
|---|---|---|---|
| * | K992510 | Wallstent Tracheobronchial Endoprosthesis and Unistep Plus Delivery SystemSummary page 4…Galway, Ireland ERN: 9681260 Predicate Devices WALLSTENT™ Tracheobronchial Endoprosthesis K992510 cleared November 18, 1999. Boston Scientific Corporation Pa… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2018 | Class II | Z-3036-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3040-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3037-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3035-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3039-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 6 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. 2016, 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 WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152842: Wallstent RP Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis Tracheobronchial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152842
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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