510(k) · Cleared
ClearedWallstent 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 21, 1998 as substantially equivalent to K980163 (Boston Scientific Scimed, Inc., 1998) and 7 other predicates after a 29-day review. Its family tree reaches back 5 generations to 1992. 40 later devices descend from it.
- Decided
- Jul 21, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- JCT
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K923119 (1992). 14 ancestors in all, the oldest K911292 (1991). 40 later devices descend from it, 3 citing it directly.
- 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 backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- This deviceK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · cites it directly · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- Descendant · 2 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 2 generations on · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- Descendant · 3 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · cites it directly · 10 of its ownK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · cites it directly37descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 2 generations on23descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · 2 generations on11descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 3 generations on10descendants
- K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006 · cites it directly10descendants
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 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| 0 (this device) | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +1 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| +2 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +2 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| +3 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +1 | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 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 |
| 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? (8)
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 |
|---|---|---|---|
| * | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis… Our OCR of the scanned summary read K880163, FDA’s number for Pregnancy (HCG) Card & Liquid Test (Ampcor, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “WALLSTENT® Tracheobronchial Endoprosthesis (12-30 mm)”. | 1998 |
| * | K980113 | Wallstent Enteral EndoprosthesisSummary page 9…B()S‘[onfiC cienti Predicate Device 1 Device Description \c”i%?/@‘/ P ot 7 WALLSTENT® K880163 March 13, 1998 Tracheobronchial Endoprosthesis (12-30 mm) WALLSTENT® K980113 Enteral Endoprosthesis (Duodenal) April 3, 1998 WALLSTENT® Tracheobronchial Endoprosthesis (5-10 mm) K964121 December 4, 1996… | 1998 |
| * | K964121 | Wallstent Tracheobronchial EndoprosthesisSummary page 9…Tracheobronchial Endoprosthesis (12-30 mm) WALLSTENT® K980113 Enteral Endoprosthesis (Duodenal) April 3, 1998 WALLSTENT® Tracheobronchial Endoprosthesis (5-10 mm) K964121 December 4, 1996 K964119 April 28, 1997 WALLSTENT® Biliary (8-10 mm) (Endoscopic and Transhepatic) K961262 May 16, 1996 WALL… | 1996 |
| * | K964119 | Wallstent Transhepatic Biliary EndoprosthesisSummary page 9…thesis (12-30 mm) WALLSTENT® K980113 Enteral Endoprosthesis (Duodenal) April 3, 1998 WALLSTENT® Tracheobronchial Endoprosthesis (5-10 mm) K964121 December 4, 1996 K964119 April 28, 1997 WALLSTENT® Biliary (8-10 mm) (Endoscopic and Transhepatic) K961262 May 16, 1996 WALLSTENT® Biliary (12 mm) (En… | 1997 |
| * | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisSummary page 9…998 WALLSTENT® Tracheobronchial Endoprosthesis (5-10 mm) K964121 December 4, 1996 K964119 April 28, 1997 WALLSTENT® Biliary (8-10 mm) (Endoscopic and Transhepatic) K961262 May 16, 1996 WALLSTENT® Biliary (12 mm) (Endoscopic and Transhepatic) K954290 July 10, 1996 WALLSTENT® Enteral Endoprosthesis… | 1996 |
| * | K954290 | Wallstent Enteral EndoprothesisSummary page 9…996 K964119 April 28, 1997 WALLSTENT® Biliary (8-10 mm) (Endoscopic and Transhepatic) K961262 May 16, 1996 WALLSTENT® Biliary (12 mm) (Endoscopic and Transhepatic) K954290 July 10, 1996 WALLSTENT® Enteral Endoprosthesis WALLSTENT® K940396 October 2, 1994 Esophageal WALLSTENT® K934116 June 2, 1994… | 1996 |
| * | K940396 | Wallstent Esophageal Prosthesis (Double)Summary page 9…and Transhepatic) K961262 May 16, 1996 WALLSTENT® Biliary (12 mm) (Endoscopic and Transhepatic) K954290 July 10, 1996 WALLSTENT® Enteral Endoprosthesis WALLSTENT® K940396 October 2, 1994 Esophageal WALLSTENT® K934116 June 2, 1994 Tracheobronchial Prosthesis The WALLSTENT® Tracheobronchial Endopr… | 1994 |
| * | K934116 | Wallstent Tracheobronchial Prosthesis ModificationSummary page 9…TENT® Biliary (12 mm) (Endoscopic and Transhepatic) K954290 July 10, 1996 WALLSTENT® Enteral Endoprosthesis WALLSTENT® K940396 October 2, 1994 Esophageal WALLSTENT® K934116 June 2, 1994 Tracheobronchial Prosthesis The WALLSTENT® Tracheobronchial Endoprosthesis is a self- expanding prosthesis constru… | 1994 |
What descends from it? (40)
See all 403 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)
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 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K012752 (Boston Scientific Corp, 2001) has gone furthest, with 37 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 WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.
The WALLSTENT® Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal 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/K982184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982184: Wallstent Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982184
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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