510(k) · Decided
DecidedEvolution Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 1, 2013 as substantially equivalent to K061231 (Boston Scientific Corp, 2006) and 3 other predicates after a 291-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Mar 1, 2013
- Review
- 291 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K923119 (1992). 22 ancestors in all, the oldest K911292 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 6 generations between
- 3 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 2 generations backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- 1 generation backK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- This deviceK121430 Evolution Biliary Stent SystemCook Ireland, Ltd. · 2013
Show all 10 generations
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 9 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 8 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 7 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 6 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 5 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 4 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 3 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 2 generations backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- 1 generation backK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- This deviceK121430 Evolution Biliary Stent SystemCook Ireland, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −9 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −8 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −7 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −6 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −5 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −4 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −3 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| −2 | 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 | — |
| 0 (this device) | K121430 | Evolution Biliary Stent System | Cook Ireland, Ltd. | 2013 | — |
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 |
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 |
|---|---|---|---|
| * | K061231 | Wellflex Biliary RX Stent SystemSummary page 1…0, Product Code: FOE) Predicate Devices: Boston Scientific WallflexTm Biliary RX Stent System (Uncovered) (K06 1231 and KO081733) and the WallstentTM RX Biliary Endoprosthesis Stent System (Uncovered)… | 2006 |
| * | K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Summary page 2…currently marketed predicate devices, Boston Scientific WallflexTM Biliary RX Stent System (Uncovered) (K061231 and K081733) and the Wallstent Tm RX Bhliary Endoprosthesis Stent System (Uncovered) (KG 12752 and… | 2008 |
| * | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveSummary page 1…(Uncovered) (K06 1231 and KO081733) and the WallstentTM RX Biliary Endoprosthesis Stent System (Uncovered) (KO012752 and K030 107). Description of the Stent Description: Device: This flexible, self-expanding stent is c… | 2001 |
| * | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMSummary page 1…vered) (K06 1231 and KO081733) and the WallstentTM RX Biliary Endoprosthesis Stent System (Uncovered) (KO012752 and K030 107). Description of the Stent Description: Device: This flexible, self-expanding stent is constructed of… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 22 ancestors have a recall of any class.
- 5 other devices also cite its predicate K061231.
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. 2013, 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?
This device is used in palliation of malignant neoplasms in the biliary tree
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121430: Evolution Biliary 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/K121430
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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