510(k) · Decided
DecidedZilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 7, 2017 as substantially equivalent to K033348 (Cook, Inc., 2003) and 5 other predicates after an 85-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Feb 7, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K033348 (2003). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentCook Ireland, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033348 | Zilver 518 Biliary Stent | Cook, Inc. | 2003 | — |
| 0 (this device) | K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. | 2017 | — |
| +1 | K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K033348 | Zilver 518 Biliary StentSummary page 6…ct Code: FGE III. PREDICATE DEVICE Predicate: Zilver® 518TM Biliary Stent (ZIB5) cleared under the following 510(k)s: Zilver® 518™ Biliary Stent (ZIB5): K033348, on December 15th, 2003 K042518, on October 1st, 2004 K050698, on March 30th, 2005 Predicate: Zilver® 635TM Biliary Stent… | 2003 |
| * | K042518 | Zilver 518 Biliary StentSummary page 6…E DEVICE Predicate: Zilver® 518TM Biliary Stent (ZIB5) cleared under the following 510(k)s: Zilver® 518™ Biliary Stent (ZIB5): K033348, on December 15th, 2003 K042518, on October 1st, 2004 K050698, on March 30th, 2005 Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following… | 2004 |
| * | K050698 | Modification to:Zilver 518 Biliary StentSummary page 6…TM Biliary Stent (ZIB5) cleared under the following 510(k)s: Zilver® 518™ Biliary Stent (ZIB5): K033348, on December 15th, 2003 K042518, on October 1st, 2004 K050698, on March 30th, 2005 Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: Zilver® 635™ Biliary… | 2005 |
| * | K040505 | Zilver 635 Biliary StentSummary page 6…er 1st, 2004 K050698, on March 30th, 2005 Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: Zilver® 635™ Biliary Stent (ZIB6): K040505, on March 16th, 2004 K043481, on December 29th, 2004 K051124, on July 12th, 2005 The predicate devices detailed above hav… | 2004 |
| * | K043481 | Modification to: Zilver 635 Biliary StentSummary page 6…h 30th, 2005 Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: Zilver® 635™ Biliary Stent (ZIB6): K040505, on March 16th, 2004 K043481, on December 29th, 2004 K051124, on July 12th, 2005 The predicate devices detailed above have not been subject to a design r… | 2004 |
| * | K051124 | Zilver 635 Biliary StentSummary page 6…5TM Biliary Stent (ZIB6) cleared under the following 510(k)s: Zilver® 635™ Biliary Stent (ZIB6): K040505, on March 16th, 2004 K043481, on December 29th, 2004 K051124, on July 12th, 2005 The predicate devices detailed above have not been subject to a design related recall. IV. DEVICE… | 2005 |
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 |
|---|---|---|---|
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | 2018 | 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?
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K182980 (Cook Ireland, Ltd., 2018) has gone furthest, with 0 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. 2017, this device’s year, is highlighted.
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 and 635 Biliary Stent are indicated for use in palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163169: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163169
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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