510(k) Report

510(k) · Cleared

Cleared

Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030

K062750510(k) TraditionalCleared Dec 4, 200681-day reviewClass II21 CFR 878.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · MUM Stent, Metallic, Expandable, Duodenal

Cleared on Dec 4, 2006 as substantially equivalent to K042065 (Boston Scientific Corp, 2004) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it.

Decided
Dec 4, 2006
Review
81 days
Class
Class II
Product code
MUM
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K000281 (2000). 3 ancestors in all. 11 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2011: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2012: 1 descendant cleared2019: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK000281 · Wallstent Enternal Prosthesis · Boston Scientific Corp · 2000K042065 · Wallflex Enternal Colonic Stent and Anchor Lock Delivery System · Boston Scientific Corp · 2004 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K042065 · Wallflex Enternal Colonic Stent and Anchor Lock Delivery System · Boston Scientific Corp · 2004 · recalledK000281 · Wallstent Enternal Prosthesis · Boston Scientific Corp · 20000
  1. Root · 2 generations backK000281 Wallstent Enternal ProsthesisBoston Scientific Corp · 2000
  2. 1 generation backK042065 Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp · 2004 · Recalled
  3. This deviceK062750 Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System…Boston Scientific Corp · 2006
  4. Descendant · cites it directly · 4 of its ownK180180 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM…M.I.Tech Co., Ltd. · 2018
  5. Descendant · cites it directly · 4 of its ownK101530 Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd. · 2011
  6. Descendant · 2 generations on · 3 of its ownK183616 HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx…M.I.Tech Co., Ltd. · 2019
  7. Descendant · 2 generations on · 3 of its ownK113510 Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012
  8. Descendant · 3 generations on · 2 of its ownK190141 HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12017: 12018: 12019: 22020: 22023: 12024: 12025: 1
2011high 2 (2019) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2018 · cites it directly4descendants
  • K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DCook Ireland, Ltd. · 2011 · cites it directly4descendants
  • K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd. · 2019 · 2 generations on3descendants
  • K113510Evolution Colonic Stent SystemCook Ireland, Ltd. · 2012 · 2 generations on3descendants
  • K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd. · 2019 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000281Wallstent Enternal ProsthesisBoston Scientific Corp2000—
−1K042065Wallflex Enternal Colonic Stent and Anchor Lock Delivery SystemBoston Scientific Corp20041
0 (this device)K062750Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models…Boston Scientific Corp2006—
+1K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus…M.I.Tech Co., Ltd.2018—
+1K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D…Cook Ireland, Ltd.2011—
+2K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.2019—
+2K113510Evolution Colonic Stent SystemCook Ireland, Ltd.2012—
+3K190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201710
201810
201920
202020
202310
202410
202510
FIG. 1 — Lineage of K062750, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250663 Niti-S Duodenal Comfort Stent, Niti-S Colonic…score 10.9 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K042065Wallflex Enternal Colonic Stent and Anchor Lock Delivery System
Summary page 1
…78.361 0 Product Code: MUM Classification: Class 11 3. Predicate Device: WallFleXTM Enteral Colonic Stent System with Anchor Lock Delivery System, K042065 Wallstent Enteral Endoprosthesis, K000281I The predicate devices are class II devices per 21 CFR 878.3610 4. Devi…
Boston Scientific Corp20041
*K000281Wallstent Enternal Prosthesis
Summary page 1
…cation: Class 11 3. Predicate Device: WallFleXTM Enteral Colonic Stent System with Anchor Lock Delivery System, K042065 Wallstent Enteral Endoprosthesis, K000281I The predicate devices are class II devices per 21 CFR 878.3610 4. Device Description: The: proposed WallFlexTM…
Boston Scientific Corp2000—

Also cleared against K042065: 2 other devices →

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.20184
K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DCook Ireland, Ltd.20114
K201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific Corporation20201
K200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal…Boston Scientific Corporation20201

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 6 years and passes through 1 company; a new generation was cleared every 4.4 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K180180 (M.I.Tech Co., Ltd., 2018) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K042065.

How does its category compare?

All MUM devices

MUM Stent, Metallic, Expandable, Duodenal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUM

1in 2025

2011: 12017: 12023: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

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

2007: 142008: 252009: 922010: 1022011: 582012: 712013: 622014: 432015: 512016: 412017: 852018: 492019: 352020: 322021: 702022: 282023: 532024: 342025: 32
2007high 102 (2010) · low 14 (2007)2025

MAUDE reports naming product code MUM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—025
20090—092
20100—0102
20111—058
20120—071
20130—062
20140—043
20150—051
20160—041
20171—085
20180—049
20190—035
20200—032
20210—070
20220—028
20231—053
20240—034
20251—032
20260—0—

What is it indicated for?

The WallFlex™ Enteral Duodenal Stent with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions caused by malignant neoplasms.

Indications for use as stated in the FDA summary.

Also cleared against K042065

2 other devices cite the same predicate.

  • K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
  • K061877Wallflex Enteral Colonic Stent with Anchor Lock Delivery SystemBoston Scientific Corp · 2006

More from Boston Scientific Corp

4,014 FDA decisions under this applicant name. See the company

  • P900056/S229ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P900056/S226ROTAPRO™ Rotational Atherectomy SystemsBoston Scientific Corp · 2026
  • P900056/S228ROTAPRO™ Rotational Atherectomy SystemBoston Scientific Corp · 2026
  • P150031/S100Vercise DBS SystemsBoston Scientific Corp · 2026
  • N970003/S311ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2…Boston Scientific Corp · 2026

Recent decisions in MUM

The MUM category page

  • K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2025
  • K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentTaewoong Medical Co., Ltd. · 2023
  • K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd. · 2017
  • K101530Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-DCook Ireland, Ltd. · 2011
  • K980113Wallstent Enteral EndoprosthesisBoston Scientific Scimed, Inc. · 1998

https://510kreport.com/device/K062750 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062750

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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