510(k) · Cleared
ClearedAgile Esophageal Stent System
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 Sep 21, 2018 as substantially equivalent to K091510 (Boston Scientific Corporation, 2009) and 3 other predicates after a 246-day review. Its family tree reaches back 10 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 21, 2018
- Review
- 246 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K923119 (1992). 45 ancestors in all, the oldest K911292 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 6 generations between
- 3 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 2 generations backK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- 1 generation backK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- This deviceK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- Descendant · cites it directly · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- Descendant · cites it directly · 1 of its ownK233837 Agile Esophageal Stent SystemBoston Scientific Corporation · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
Show all 10 generations
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 9 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 8 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 7 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 6 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 5 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 4 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 3 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 2 generations backK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- 1 generation backK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- This deviceK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · cites it directly2descendants
- K233837Agile Esophageal Stent SystemBoston Scientific Corporation · 2024 · cites it directly1descendant
- K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −9 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −8 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −7 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −6 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −5 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −4 | 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 | — |
| −2 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| −1 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| 0 (this device) | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| +1 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
| +1 | K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024 | 9 |
| +2 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent… | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 15.3 · 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? (4)
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 |
|---|---|---|---|
| * | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Summary page 4…Wallflex Esophageal Fully & Partially Covered Stent System 510(k) Number: K091510/ K073266 Classification Name: Esophageal Prosthesis Regulation Number: 21… | 2009 |
| * | K073266 | Wallflex Partially Covered Esophageal Stent SystemSummary page 4…Wallflex Esophageal Fully & Partially Covered Stent System 510(k) Number: K091510/ K073266 Classification Name: Esophageal Prosthesis Regulation Number: 21 CFR 878.… | 2008 |
| * | K123205 | Esophageal TTS StentSummary page 4…Trade Name: Taewoong Niti-S Esophageal TTS Stent 510(k) Number: K123205 Classification Name: Esophageal Prosthesis Regulation Number: 21 CFR 878.… | 2013 |
| * | K080838 | Alveolus Alimaxx-E Esophageal Stent SystemSummary page 4…Trade Name: Merit Alimaxx-ES Esophageal Stent 510(k) Number: K080838 K180144… | 2008 |
| † | K091816 | Ultraflex Esophageal NG Stent System | 2009 |
What descends from it? (3)
2 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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 15 of the 45 ancestors have a recall of any class.
- Of its descendants, K211960 (Boston Scientific Corporation, 2021) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K091510.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Agile Esophageal 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 fistulas.
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/K180144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180144: Agile Esophageal Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180144
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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