510(k) · Cleared
ClearedWallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · MQR Stent, Colonic, Metallic, Expandable
Cleared on Apr 17, 2020 as substantially equivalent to K061877 (Boston Scientific Corp, 2006) and 2 other predicates after a 74-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Apr 17, 2020
- Review
- 74 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000281 (2000). 12 ancestors in all, the oldest K954290 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
- 5 generations backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
- 4 generations backK062750 Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System…Boston Scientific Corp · 2006
- 3 generations backK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
- 2 generations backK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
- 1 generation backK163468 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent…Cook Ireland, Ltd. · 2017
- This deviceK200257 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK234046 WallFlex Colonic Stent System with Anchor Lock Delivery System…Boston Scientific Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent…Boston Scientific Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corp | 2000 | — |
| −5 | K042065 | Wallflex Enternal Colonic Stent and Anchor Lock Delivery System | Boston Scientific Corp | 2004 | 1 |
| −4 | K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models… | Boston Scientific Corp | 2006 | — |
| −3 | K101530 | Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D… | Cook Ireland, Ltd. | 2011 | — |
| −2 | K113510 | Evolution Colonic Stent System | Cook Ireland, Ltd. | 2012 | — |
| −1 | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System -… | Cook Ireland, Ltd. | 2017 | — |
| 0 (this device) | K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex… | Boston Scientific Corporation | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K061877 | Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemSummary page 4…ent System with Anchor Lock Delivery System Manufacturer: Boston Scientific Corporation Clearance Number: K061877 Common Name: Expandable, metallic colonic stent Product Code: MQR Device Class and Panel:… | 2006 |
| * | K062750 | Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010…Summary page 4…ent System with Anchor Lock Delivery System Manufacturer: Boston Scientific Corporation Clearance Number: K062750 Common Name: Expandable, metallic duodenal stent 6SHFLDO N 3UHPDUNHW1RWLILFDWLRQ:DO… | 2006 |
| * | K163468 | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredSummary page 5…ncovered, Evolution Colonic Stent System - Uncovered Manufacturer: Cook Ireland Ltd. Clearance Number: K163468 Common Name: Expandable, metallic duodenal stent Product Code: MUM, MQR Device Class and P… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent… | 2024 | 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 20 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K234046 (Boston Scientific Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K061877.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200257: WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200257
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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