510(k) · Decided
Recalled · 2004Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 15, 2001 as substantially equivalent to K000308 (Boston Scientific Corp, 2000) and 3 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1992. 37 later devices descend from it. It has been recalled once.
- Decided
- Nov 15, 2001
- Review
- 91 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K923119 (1992). 16 ancestors in all, the oldest K911292 (1991). 37 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 5 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 4 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 3 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 2 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 1 generation backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- This deviceK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001
- Descendant · cites it directly · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · cites it directly · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- Descendant · 2 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
- Descendant · 3 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · cites it directly23descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · cites it directly11descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 2 generations on10descendants
- K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006 · cites it directly10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −5 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −4 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −3 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −2 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −1 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| 0 (this device) | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | — |
| +1 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +1 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| +2 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +1 | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
| +3 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K000308 | Wallstent Biliary EndoprosthesisSummary page 1…nt RX Biliary Endoprostheses Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories 3. Predicate Device: BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262 4. Device Description: The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a d… | 2000 |
| * | K982184 | Wallstent EndoprosthesisSummary page 1…iary Endoprostheses Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories 3. Predicate Device: BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262 4. Device Description: The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a delivery c… | 1998 |
| * | K964119 | Wallstent Transhepatic Biliary EndoprosthesisSummary page 1…prostheses Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories 3. Predicate Device: BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262 4. Device Description: The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a delivery catheter.… | 1997 |
| * | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisSummary page 1…Common Name: Biliary Stent Classification Name: Biliary Catheter & Accessories 3. Predicate Device: BSC Wallstent Biliary Endoprostheses - K000308, K982184, K964119, & K961262 4. Device Description: The proposed Wallstent RX Biliary Endoprostheses consists of a stent and a delivery catheter. The self-ex… | 1996 |
What descends from it? (37)
See all 377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073667 | Niti-S Biliary Stent | 2008 | 23 |
| K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | 2003 | 11 |
| K061231 | Wellflex Biliary RX Stent System | 2006 | 10 |
| K083374 | Wallflex Biliary RX Partially-Covered Stent System | 2009 | 6 |
| K083627 | Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520… | 2009 | 6 |
| K121430 | Evolution Biliary Stent System | 2013 | 0 |
| K081956 | Medinol X-Suit Nir Biliary Metallic Stent | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2004 | Not classified | Z-0563-04 | Other | Incorrect label states stent covered with 'Permalume Covering', product is uncovered |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K073667 (Taewoong Medical Co., Ltd., 2008) has gone furthest, with 23 descendants of its own.
- 3 other devices also cite its predicate K000308.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Wallstent™ RX Biliary Endoprosthesis is indicated for palliative treatment of biliary 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/K012752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012752: Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012752
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026