510(k) · Cleared
ClearedWallstent Enteral Endoprothesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · MQR Stent, Colonic, Metallic, Expandable
Cleared on Jul 10, 1996 after a 300-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Jul 10, 1996
- Review
- 300 days
- Class
- Class II
- Product code
- MQR
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly.
- This deviceK954290 Wallstent Enteral EndoprothesisBoston Scientific Scimed, Inc. · 1996
- Descendant · cites it directly · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · 2 generations on · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 3 generations on · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- Descendant · 4 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · cites it directly40descendants
- K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · 2 generations on37descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · 3 generations on11descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954290 | Wallstent Enteral Endoprothesis | Boston Scientific Scimed, Inc. | 1996 | — |
| +1 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +2 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| +3 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +3 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| +4 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | — | WALLSTENT® Esophageal Prosthesis Named without a submission number |
What descends from it? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K982184 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 40 descendants of its own.
How does its category compare?
All MQR devicesMQR Stent, Colonic, Metallic, Expandable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Schneider WALLSTENT® Enteral Endoprosthesis is indicated for the palliative treatment of colonic strictures 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/K954290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954290: Wallstent Enteral Endoprothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954290
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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