510(k) · Cleared
ClearedWallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · ESW Prosthesis, Esophageal
Cleared on Jun 26, 2009 as substantially equivalent to K073266 (Boston Scientific Corp, 2008) and 2 other predicates after a 35-day review. Its family tree reaches back 4 generations to 1995. 14 later devices descend from it.
- Decided
- Jun 26, 2009
- Review
- 35 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K925406 (1995). 16 ancestors in all, the oldest K940838 (1994). 14 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 3 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- 2 generations backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- 1 generation backK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- This deviceK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- Descendant · cites it directly · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- Descendant · cites it directly · 3 of its ownK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- Descendant · 2 generations on · 2 of its ownK201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK092144 Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S.…Endochoice, Inc. · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · cites it directly3descendants
- K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018 · cites it directly3descendants
- K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · cites it directly2descendants
- K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021 · 2 generations on2descendants
- K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −3 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| −2 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| −1 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| +1 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| +1 | K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +1 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
| +2 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021 | — |
| +1 | K092144 | Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange… | Endochoice, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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 ESW? 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 ESW device
- #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 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 |
|---|---|---|---|
| * | K073266 | Wallflex Partially Covered Esophageal Stent SystemSummary page 1…21 CFR 878.3610 Product Code: ESW Classification: Class II 3. Predicate Device: WallFlex Esophageal Partially Covered Stent System K073266 Manufactured by Boston Scientific, Inc. ALIMAXX-E Esophageal Stent System… | 2008 |
| * | K051621 | Endoventions Alimaxx-E Esophageal Stent SystemSummary page 1…red Stent System K073266 Manufactured by Boston Scientific, Inc. ALIMAXX-E Esophageal Stent System K051621, K080838 Manufactured by Alveolus, Inc 4. Device Description: The proposed WallFlex Esophageal Fully Covere… | 2005 |
| * | K080838 | Alveolus Alimaxx-E Esophageal Stent SystemSummary page 1…System K073266 Manufactured by Boston Scientific, Inc. ALIMAXX-E Esophageal Stent System K051621, K080838 Manufactured by Alveolus, Inc 4. Device Description: The proposed WallFlex Esophageal Fully Covered Stent S… | 2008 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180144 | Agile Esophageal Stent System | 2018 | 3 |
| K172813 | Esophageal Stent System | 2018 | 3 |
| K211960 | Agile Esophageal OTW Stent System | 2021 | 2 |
| K092144 | Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare… | 2010 | 2 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | 2024 | 1 |
| K141584 | Ultraflex Tracheobronchial Covered Stent System | 2014 | 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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K180144 (Boston Scientific Corporation, 2018) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K073266.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ESW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
MAUDE reports naming product code ESW, 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 | 88 |
| 2008 | 5 | 99 | 0 | 153 |
| 2009 | 3 | 35 | 0 | 239 |
| 2010 | 3 | 206 | 25 | 255 |
| 2011 | 1 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 121 |
| 2013 | 2 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 175 |
| 2016 | 1 | — | 0 | 153 |
| 2017 | 0 | — | 0 | 87 |
| 2018 | 2 | — | 0 | 86 |
| 2019 | 1 | — | 0 | 167 |
| 2020 | 1 | — | 0 | 155 |
| 2021 | 4 | 139 | 0 | 77 |
| 2022 | 1 | — | 0 | 109 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 4 | 130 | 0 | 166 |
| 2025 | 3 | 90 | 0 | 120 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091510
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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