510(k) · Cleared
ClearedEvolution Esophageal Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · ESW Prosthesis, Esophageal
Cleared on May 9, 2008 as substantially equivalent to K011591 (Wilson-Cook Medical, Inc., 2002) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K920218 (1994). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920218 Esophageal Z-StentWilson-Cook Medical, Inc. · 1994 · Recalled
- 1 generation backK011591 Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc. · 2002
- This deviceK080359 Evolution Esophageal Stent SystemCook Ireland, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK093619 Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E…Cook Ireland, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK162717 Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920218 | Esophageal Z-Stent | Wilson-Cook Medical, Inc. | 1994 | 1 |
| −1 | K011591 | Esophageal Z-Stent with Dua Anti-Reflux Valve | Wilson-Cook Medical, Inc. | 2002 | — |
| 0 (this device) | K080359 | Evolution Esophageal Stent System | Cook Ireland, Ltd. | 2008 | — |
| +1 | K093619 | Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E… | Cook Ireland, Ltd. | 2010 | — |
| +1 | K162717 | Evolution Esophageal Stent System – Partially Covered | Cook Ireland, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K011591 | Esophageal Z-Stent with Dua Anti-Reflux Valve | 2002 |
| * | K940395 | Wallstent Esophageal ProsthesisSummary page 1…nti-Reflux Valve (KO1 1591) Wallstent II Esophageal Prosthesis (K940395) UltraflexTM Esophageal NG Stent System… | 1994 |
| * | K032930 | Ultraflex Esophageal NG Stent SystemSummary page 1…al Prosthesis (K940395) UltraflexTM Esophageal NG Stent System (K032930). Description of the Device: Stent Description: Thi… | 2003 |
What descends from it? (2)
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 14 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K093619 (Cook Ireland, Ltd., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K011591.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
This device is used to maintain patency of malignant esophageal strictures and / or to seal tracheoesophageal fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080359: Evolution Esophageal Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080359
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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