510(k) · Decided
DecidedCook Zilver Biliary Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 13, 2001 after a 200-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.
- Decided
- Aug 13, 2001
- Review
- 200 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 2 citing it directly.
- This deviceK010242 Cook Zilver Biliary StentCook, Inc. · 2001
- Descendant · cites it directly · 32 of its ownK020788 Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 24 of its ownK040930 Zilver Biliary Stent System UswWilson-Cook Medical, Inc. · 2004
- Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 4 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · 5 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K020788Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. · 2002 · cites it directly32descendants
- K040930Zilver Biliary Stent System UswWilson-Cook Medical, Inc. · 2004 · 2 generations on24descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 4 generations on10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010242 | Cook Zilver Biliary Stent | Cook, Inc. | 2001 | — |
| +1 | K020788 | Wilson-Cook Zilver Biliary Stent | Wilson-Cook Medical, Inc. | 2002 | 3 |
| +2 | K040930 | Zilver Biliary Stent System Usw | Wilson-Cook Medical, Inc. | 2004 | — |
| +3 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +4 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +5 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (33)
See all 332 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?
- Of its descendants, K020788 (Wilson-Cook Medical, Inc., 2002) has gone furthest, with 32 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
https://510kreport.com/device/K010242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010242: Cook Zilver Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010242
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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