510(k) · Cleared
ClearedEvolution Colonic Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · MQR Stent, Colonic, Metallic, Expandable
Cleared on May 17, 2012 as substantially equivalent to K000281 (Boston Scientific Corp, 2000) and 2 other predicates after a 171-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- May 17, 2012
- Review
- 171 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000281 (2000). 10 ancestors in all, the oldest K954290 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 3 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 2 generations backK062750 Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System…Boston Scientific Corp · 2006
- 1 generation backK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
- This deviceK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK234046 WallFlex Colonic Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd. · 2017 · cites it directly2descendants
- K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation · 2020 · 2 generations on1descendant
- K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −3 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −2 | K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models… | Boston Scientific Corp | 2006 | — |
| −1 | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… | Cook Ireland, Ltd. | 2011 | — |
| 0 (this device) | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| +1 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
| +2 | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex… | Boston Scientific Corporation | 2020 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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 MQR? 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 MQR device
- #1 K234046 WallFlex Colonic Stent System with Anchor Lock…score 8.8 · 7 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 |
|---|---|---|---|
| * | K000281 | Wallstent Enternal ProsthesisSummary page 1…Predicate Devices: Boston Scientific Walistent®O Enteral Endoprosthesis with UnistepTrM Plus Delivery System (K000281) Boston Scientific WaIIFlexTm Enteral Colonic Stent with… | 2000 |
| * | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemSummary page 1…000281) Boston Scientific WaIIFlexTm Enteral Colonic Stent with Anchor Lock Delivery System (K061 877) Cook Evolution®D Duodenal Stent System (KI101530) Page 1 of 4 KI 13510… | 2006 |
| * | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DSummary page 1…c Stent with Anchor Lock Delivery System (K061 877) Cook Evolution®D Duodenal Stent System (KI101530) Page 1 of 4 KI 13510; Cook Ireland Evolutione Colonic Stent System Description of the Device:… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | 2017 | 2 |
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 12 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K163468 (Cook Ireland, Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K000281.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MQR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQR
Too few MQR 510(k)s in any year since 2007 to give a median.
Recalls per year · MQR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQR
29in 2025
MAUDE reports naming product code MQR, 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 | 30 |
| 2008 | 0 | — | 0 | 144 |
| 2009 | 0 | — | 0 | 153 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 1 | — | 0 | 104 |
| 2013 | 0 | — | 0 | 100 |
| 2014 | 0 | — | 0 | 70 |
| 2015 | 0 | — | 0 | 72 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 1 | — | 0 | 44 |
| 2019 | 2 | — | 0 | 42 |
| 2020 | 2 | — | 0 | 46 |
| 2021 | 0 | — | 0 | 56 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 38 |
| 2024 | 1 | — | 0 | 70 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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/K113510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113510: Evolution Colonic 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/K113510
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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