510(k) · Cleared
ClearedEvolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · MUM Stent, Metallic, Expandable, Duodenal
Cleared on May 4, 2017 as substantially equivalent to K101530 (Cook Ireland, Ltd., 2011) and 1 other predicate after a 143-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- May 4, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- MUM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000281 (2000). 11 ancestors in all, the oldest K954290 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 4 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 3 generations backK062750 Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System…Boston Scientific Corp · 2006
- 2 generations backK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
- 1 generation backK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- This deviceK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK234046 WallFlex Colonic Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2024
Most influential descendants
Showing 2 of 2 · See all- K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation · 2020 · cites it directly1descendant
- K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −4 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −3 | K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models… | Boston Scientific Corp | 2006 | — |
| −2 | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… | Cook Ireland, Ltd. | 2011 | — |
| −1 | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| 0 (this device) | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
| +1 | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex… | Boston Scientific Corporation | 2020 | — |
| +2 | K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex… | Boston Scientific Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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 MUM? 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 MUM device
- #1 K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic…score 10.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DSummary page 5…468 Evolution® Duodenal Stent System and Evolution® Colonic Stent System Page 2 of 4 III. PREDICATE DEVICE Evolution™ Duodenal Stent System, K101530 cleared March 29, 2011. Evolution™ Colonic Stent System, K113510 cleared May 17, 2012. The predicate devices detailed above hav… | 2011 |
| * | K113510 | Evolution Colonic Stent SystemSummary page 5…System Page 2 of 4 III. PREDICATE DEVICE Evolution™ Duodenal Stent System, K101530 cleared March 29, 2011. Evolution™ Colonic Stent System, K113510 cleared May 17, 2012. The predicate devices detailed above have never been subject to a design related recall. IV. DEVIC… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal… | 2020 | 1 |
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 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K200257 (Boston Scientific Corporation, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K101530.
How does its category compare?
All MUM devicesMUM Stent, Metallic, Expandable, Duodenal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MUM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUM
Too few MUM 510(k)s in any year since 2007 to give a median.
Recalls per year · MUM
No recall names MUM since 2007.
Adverse event reports per year · MUM
32in 2025
MAUDE reports naming product code MUM, 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 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 102 |
| 2011 | 1 | — | 0 | 58 |
| 2012 | 0 | — | 0 | 71 |
| 2013 | 0 | — | 0 | 62 |
| 2014 | 0 | — | 0 | 43 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 41 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 70 |
| 2022 | 0 | — | 0 | 28 |
| 2023 | 1 | — | 0 | 53 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Evolution® Duodenal Stent System- Uncovered: This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.
Evolution® Colonic Stent System- Uncovered: This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163468 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163468: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163468
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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