510(k) · Decided
DecidedWellflex Biliary RX Stent System
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 Sep 1, 2006 as substantially equivalent to K000308 (Boston Scientific Corp, 2000) and 6 other predicates after a 122-day review. Its family tree reaches back 8 generations to 1992. 10 later devices descend from it.
- Decided
- Sep 1, 2006
- Review
- 122 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K923119 (1992). 20 ancestors in all, the oldest K911292 (1991). 10 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 7 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 6 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 5 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 4 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 3 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 2 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 1 generation backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- This deviceK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- Descendant · cites it directly · 7 of its ownK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- Descendant · cites it directly · 6 of its ownK083374 Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 2009
- Descendant · cites it directly · 6 of its ownK083627 Wallflex Biliary RX Fully-Covered Stent System, Model…Boston Scientific Corporation · 2009
- Descendant · cites it directly · 5 of its ownK112543 Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex…Boston Scientific Corporation · 2011
- Descendant · cites it directly · 4 of its ownK122072 Wallflextm Biliary RX Stent System (Uncovered, Partially Covered…Boston Scientific Corporation · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp · 2008 · cites it directly7descendants
- K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 2009 · cites it directly6descendants
- K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation · 2009 · cites it directly6descendants
- K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation · 2011 · cites it directly5descendants
- K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation · 2012 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −7 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −6 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −5 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −4 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −3 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −2 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −1 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| 0 (this device) | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
| +1 | K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 | Boston Scientific Corp | 2008 | — |
| +1 | K083374 | Wallflex Biliary RX Partially-Covered Stent System | Boston Scientific Corp | 2009 | — |
| +1 | K083627 | Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510… | Boston Scientific Corporation | 2009 | — |
| +1 | K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary… | Boston Scientific Corporation | 2011 | — |
| +1 | K122072 | Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully… | Boston Scientific Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (7)
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…umber: 876.5010 Product Code: FGE Classification: Class II 3. Predicate Device: Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K0127… | 2000 |
| * | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemSummary page 1…6.5010 Product Code: FGE Classification: Class II 3. Predicate Device: Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and… | 1999 |
| * | K982184 | Wallstent EndoprosthesisSummary page 1…duct Code: FGE Classification: Class II 3. Predicate Device: Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107… | 1998 |
| * | K964119 | Wallstent Transhepatic Biliary EndoprosthesisSummary page 1…: FGE Classification: Class II 3. Predicate Device: Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107 The… | 1997 |
| * | K925406 | Biliary Endoprostheses W/Unistep Delivery SystemSummary page 1…Classification: Class II 3. Predicate Device: Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107 The predicate de… | 1995 |
| * | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveSummary page 1…n's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107 The predicate devices are class II devices per 21 CFR 876.5010 4. Device Description: The pro… | 2001 |
| * | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMSummary page 1…y Endoprosthesis, K000308, K993232, K982184, K964119 and K925406 Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107 The predicate devices are class II devices per 21 CFR 876.5010 4. Device Description: The proposed WallFlexTM Bil… | 2003 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 | 2008 | 7 |
| K083374 | Wallflex Biliary RX Partially-Covered Stent System | 2009 | 6 |
| K083627 | Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520… | 2009 | 6 |
| K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic… | 2011 | 5 |
| K122072 | Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)… | 2012 | 4 |
| K121430 | Evolution Biliary Stent System | 2013 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 20 ancestors have a recall of any class.
- Of its descendants, K081733 (Boston Scientific Corp, 2008) has gone furthest, with 7 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 WallFlex Biliary RX Uncovered Stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061231: Wellflex Biliary RX Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061231
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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