510(k) · Cleared
ClearedEvolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E, Evo-FC-18-23-12-E
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 Jun 17, 2010 as substantially equivalent to K080359 (Cook Ireland, Ltd., 2008) after a 206-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jun 17, 2010
- Review
- 206 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920218 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK920218 Esophageal Z-StentWilson-Cook Medical, Inc. · 1994 · Recalled
- 2 generations backK011591 Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc. · 2002
- 1 generation backK080359 Evolution Esophageal Stent SystemCook Ireland, Ltd. · 2008
- This deviceK093619 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 1 of 1 · See all- K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920218 | Esophageal Z-Stent | Wilson-Cook Medical, Inc. | 1994 | 1 |
| −2 | K011591 | Esophageal Z-Stent with Dua Anti-Reflux Valve | Wilson-Cook Medical, Inc. | 2002 | — |
| −1 | K080359 | Evolution Esophageal Stent System | Cook Ireland, Ltd. | 2008 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 15.3 · 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? (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 |
|---|---|---|---|
| * | K080359 | Evolution Esophageal Stent SystemSummary page 2…the Evolution Tm Esophageal Stent System, as cleared by K080359. Performance Data: The risks associatedlwith the modifications to… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162717 | Evolution Esophageal Stent System – Partially Covered | 2016 | 0 |
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 16 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K162717 (Cook Ireland, Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K080359.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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/K093619 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093619: Evolution Esophageal Stent Fully Covered, Models Evo-FC-18-23-8-E, Evo-FC-18-23-10-E, Evo-FC-18-23-12-E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093619
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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