510(k) · Cleared
Recalled · Class II · 2018Modification to:Zilver 518 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 Mar 30, 2005 after a 13-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 30, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 11
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK050698 Modification to:Zilver 518 Biliary StentCook, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK163169 Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentCook Ireland, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK182980 Zilver 518 Biliary Stent, Zilver 635 Biliary StentCook Ireland, Ltd. · 2018
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 |
|---|---|---|---|---|---|
| 0 (this device) | K050698 | Modification to:Zilver 518 Biliary Stent | Cook, Inc. | 2005 | — |
| +1 | K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. | 2017 | — |
| +2 | K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2018 | Class II | Z-0316-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0318-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0320-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0317-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0321-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0351-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0314-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0315-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0319-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0322-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0323-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163169 (Cook Ireland, Ltd., 2017) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Zilver® 518™ Biliary Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050698: Modification to:Zilver 518 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/K050698
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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