510(k) · Decided
DecidedWallflex Biliary RX Partially-Covered 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 Apr 22, 2009 as substantially equivalent to K012752 (Boston Scientific Corp, 2001) and 2 other predicates after a 160-day review. Its family tree reaches back 9 generations to 1992. 6 later devices descend from it.
- Decided
- Apr 22, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K923119 (1992). 21 ancestors in all, the oldest K911292 (1991). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 5 generations between
- 3 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 2 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 1 generation backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- This deviceK083374 Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 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
- Descendant · 2 generations on · 3 of its ownK140630 Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System…Boston Scientific · 2024
- Descendant · 3 generations on · 1 of its ownK223469 WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation · 2023
Show all 9 generations
- Root · 9 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 8 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 7 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 6 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 5 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 4 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 3 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 2 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 1 generation backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- This deviceK083374 Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K140630Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · 2 generations on3descendants
- K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific · 2024 · 3 generations on1descendant
- K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −8 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −7 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −6 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −5 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −4 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −3 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −2 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| −1 | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
| 0 (this device) | K083374 | Wallflex Biliary RX Partially-Covered Stent System | Boston Scientific Corp | 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 | — |
| +2 | K140630 | Wallflex Biliary RX Stent System | Boston Scientific | 2014 | 1 |
| +3 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary… | Boston Scientific | 2024 | — |
| +3 | K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | 2023 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveSummary page 1…on Number: 876.5010 Product Code: FGE Classification: Class 11 3. Predicate Device: WallStent TM RX Biliary Endoprosthesis K012752, K030107 Manufactured by Boston Scientific, Inc. WallFlex® Biliary RX Uncovered Stent System… | 2001 |
| * | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMSummary page 1…: 876.5010 Product Code: FGE Classification: Class 11 3. Predicate Device: WallStent TM RX Biliary Endoprosthesis K012752, K030107 Manufactured by Boston Scientific, Inc. WallFlex® Biliary RX Uncovered Stent System K06… | 2003 |
| * | K061231 | Wellflex Biliary RX Stent SystemSummary page 1…sis K012752, K030107 Manufactured by Boston Scientific, Inc. WallFlex® Biliary RX Uncovered Stent System K061231 Manufactured by Boston Scientific, Inc. 4. Device Description: The WallFlex Biliary RX Partially Covere… | 2006 |
What descends from it? (6)
2 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 17 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K112543 (Boston Scientific Corporation, 2011) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K012752.
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. 2009, this device’s year, is highlighted.
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?
WallFlex® Biliary RX Partially Covered 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/K083374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083374: Wallflex Biliary RX Partially-Covered Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083374
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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