510(k) · Decided

Decided

Zilver 635 Biliary Stent

K163018510(k) TraditionalDecided Dec 23, 201653-day reviewClass II21 CFR 876.5010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Ireland, Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Dec 23, 2016 as substantially equivalent to K040505 (Cook, Inc., 2004) and 4 other predicates after a 53-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.

Decided: Dec 23, 2016
Review: 53 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K010242 (2001). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK010242 Cook Zilver Biliary StentCook, Inc. · 2001
1 generation backK020788 Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. · 2002 · Recalled
This deviceK163018 Zilver 635 Biliary StentCook Ireland, Ltd. · 2016
Descendant · cites it directly · 2 of its ownK171809 Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation · 2017
Descendant · 2 generations on · 1 of its ownK240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System…Boston Scientific · 2024
Descendant · 3 generations on · 0 of its ownK242950 WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024

Most influential descendants

Showing 3 of 3 · See all

K171809Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation · 2017 · cites it directly2descendants
K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific · 2024 · 2 generations on1descendant
K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010242	Cook Zilver Biliary Stent	Cook, Inc.	2001	—
−1	K020788	Wilson-Cook Zilver Biliary Stent	Wilson-Cook Medical, Inc.	2002	3
0 (this device)	K163018	Zilver 635 Biliary Stent	Cook Ireland, Ltd.	2016	—
+1	K171809	Epic Biliary Endoscopic Stent System	Boston Scientific Corporation	2017	—
+2	K240464	WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary…	Boston Scientific	2024	—
+3	K242950	WallFlex Biliary PLUS RX Stent System	Boston Scientific	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2024	2	0

FIG. 1 — Lineage of K163018, 2001–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K040505	Zilver 635 Biliary Stent Summary page 6 …635® Biliary Stent Page 7 of 119 III. PREDICATE DEVICE Primary Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: K040505 cleared on Mar 16, 2004 K043481 cleared on Dec 29, 2004 K051124 cleared on July 12, 2005 K080037 cleared on Aug 01, 2008 Second…	Cook, Inc.	2004	—
*	K043481	Modification to: Zilver 635 Biliary Stent Summary page 6 …Page 7 of 119 III. PREDICATE DEVICE Primary Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: K040505 cleared on Mar 16, 2004 K043481 cleared on Dec 29, 2004 K051124 cleared on July 12, 2005 K080037 cleared on Aug 01, 2008 Second Predicate: Zilver® Biliary Sten…	Cook, Inc.	2004	28
*	K051124	Zilver 635 Biliary Stent Summary page 6 …ICATE DEVICE Primary Predicate: Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: K040505 cleared on Mar 16, 2004 K043481 cleared on Dec 29, 2004 K051124 cleared on July 12, 2005 K080037 cleared on Aug 01, 2008 Second Predicate: Zilver® Biliary Stent (ZILBS) cleared under the foll…	Cook, Inc.	2005	4
*	K080037	Modification to Zilver 635 Biliary Stent Summary page 6 …Zilver® 635TM Biliary Stent (ZIB6) cleared under the following 510(k)s: K040505 cleared on Mar 16, 2004 K043481 cleared on Dec 29, 2004 K051124 cleared on July 12, 2005 K080037 cleared on Aug 01, 2008 Second Predicate: Zilver® Biliary Stent (ZILBS) cleared under the following 510(k): K020788 cleared on…	Cook, Inc.	2008	—
*	K020788	Wilson-Cook Zilver Biliary Stent Summary page 6 …ed on Dec 29, 2004 K051124 cleared on July 12, 2005 K080037 cleared on Aug 01, 2008 Second Predicate: Zilver® Biliary Stent (ZILBS) cleared under the following 510(k): K020788 cleared on May 08, 2002 IV. DEVICE DESCRIPTION The Zilver 635® Biliary Stent (ZILBS-635) consists of the following two…	Wilson-Cook Medical, Inc.	2002	3

Also cleared against K040505: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K171809	Epic Biliary Endoscopic Stent System	Boston Scientific Corporation	2017	2

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 15 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
3 of the 6 ancestors have a recall of any class.
Of its descendants, K171809 (Boston Scientific Corporation, 2017) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K040505.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)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?

This device is used in palliation of malignant neoplasms in the biliary tree.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K163018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163018: Zilver 635 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/K163018

Report an extraction error

Are you the manufacturer?

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