510(k) · Cleared
Recalled · 2003Esophageal Z-Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · ESW Prosthesis, Esophageal
Cleared on Feb 9, 1994 after a 755-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it. It has been recalled once.
- Decided
- Feb 9, 1994
- Review
- 755 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 1
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK920218 Esophageal Z-StentWilson-Cook Medical, Inc. · 1994
- Descendant · cites it directly · 19 of its ownK011591 Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc. · 2002
- Descendant · 2 generations on · 15 of its ownK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 3 of its ownK211706 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K011591Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc. · 2002 · cites it directly19descendants
- K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · 2 generations on15descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 3 generations on10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 3 generations on9descendants
- K211706Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920218 | Esophageal Z-Stent | Wilson-Cook Medical, Inc. | 1994 | — |
| +1 | K011591 | Esophageal Z-Stent with Dua Anti-Reflux Valve | Wilson-Cook Medical, Inc. | 2002 | — |
| +2 | K080782 | Niti-S Esophageal Stent | Taewoong Medical Co., Ltd. | 2009 | 1 |
| +3 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +3 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| +4 | K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011591 | Esophageal Z-Stent with Dua Anti-Reflux Valve | 2002 | 19 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2003 | Not classified | Z-1410-04 | Other | Label contains the 'Sterile EO' symbol, however the device is provided non-sterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011591 (Wilson-Cook Medical, Inc., 2002) has gone furthest, with 19 descendants of its own.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K920218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920218: Esophageal Z-Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920218
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026