510(k) · Cleared

Cleared

Cordis Biliary Stent

K955728510(k) TraditionalCleared May 8, 1996142-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

Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on May 8, 1996 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 8 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1989. 8 later devices descend from it.

Decided: May 8, 1996
Review: 142 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 9

Its longest line of descent runs back 1 generation to K885180 (1989). 9 ancestors in all. 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK885180 Expandable Biliary Stent EndoprosthesisSchneider Intl., Ltd. · 1989
This deviceK955728 Cordis Biliary StentCordis Corp. · 1996
Descendant · cites it directly · 7 of its ownK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
Descendant · 2 generations on · 3 of its ownK991929 IntrastentIntratherapeutics, Inc. · 1999
Descendant · 2 generations on · 2 of its ownK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
Descendant · 3 generations on · 1 of its ownK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
Descendant · 3 generations on · 0 of its ownK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998high 3 (1999) · low 0 (2001)2026

Most influential descendants

Showing 5 of 8 · See all

K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998 · cites it directly7descendants
K991929IntrastentIntratherapeutics, Inc. · 1999 · 2 generations on3descendants
K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp. · 1999 · 2 generations on2descendants
K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · 3 generations on1descendant
K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K885180	Expandable Biliary Stent Endoprosthesis	Schneider Intl., Ltd.	1989	—
0 (this device)	K955728	Cordis Biliary Stent	Cordis Corp.	1996	—
+1	K980653	Perflex Stainless Steel Stent and Delivery System	Cordis Corp.	1998	—
+2	K991929	Intrastent	Intratherapeutics, Inc.	1999	—
+2	K992319	RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System	Guidant Corp.	1999	—
+3	K993904	Intrastent Doublestrut LD	Intratherapeutics, Inc.	2000	1
+3	K060817	Omnilink. 018 Biliary Stent System	Guidant Endovascular Solutions, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	2	0
1990	1	0
1991	4	0
1992	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	3	0
2000	1	0
2002	1	0
2006	2	0

FIG. 1 — Lineage of K955728, 1989–2006Source: 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? (9)

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
*	K905720	Palmaz Biliary Stent Summary page 1 …al Name: Biliary Stents Proprietary Name: Cordis 3iliary Stent Name of Predicate Devices 1. Johnson & Johnson Interventional Systems Paimaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292…	Johnson & Johnson Interventional Systems	1991	—
*	K911581	Palmaz (TM) Balloon-Expandable Stent, Modification Summary page 1 …iary Stents Proprietary Name: Cordis 3iliary Stent Name of Predicate Devices 1. Johnson & Johnson Interventional Systems Paimaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) f…	Johnson & Johnson Interventional Systems	1991	—
*	K885180	Expandable Biliary Stent Endoprosthesis Summary page 1 …Interventional Systems Paimaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K90385…	Schneider Intl., Ltd.	1989	—
*	K896163	Schneider Stent Wallstent Endoscopic Biliary Endo. Summary page 1 …tional Systems Paimaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K88261…	Schneider Stent	1989	—
*	K911292	Schneider Wallstent (R) Summary page 1 …stems Paimaz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for in…	Pfizer Hospital Products Group, Inc.	1991	—
*	K914277	Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY Summary page 1 …maz™ Balloon Expandable Stent (K905720 and K911581) for design and intended use. 2. Schneider Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for intended us…	Schneider U.S. Stent Div.	1991	—
*	K921191	Gianturco-Rosch Biliary Z Stent Summary page 1 …Wallstent® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for intended use and design. Classification Class ll, 21CFR 876.5010, Biliary Catheters and Accessories. Pe…	Cook, Inc.	1992	—
*	K903858	Cook-Gianturco Rosch Biliary Z-Stent, Modification Summary page 1 …® Transhepatic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for intended use and design. Classification Class ll, 21CFR 876.5010, Biliary Catheters and Accessories. Performance…	Cook, Inc.	1990	—
*	K882610	Cook-Gianturco Biliary Z Stent Summary page 1 …patic Biliary Endoprosthesis (K885180, K896163, K911292, K914277) for intended Jse and design. 3. Cook Incorporated Gianturco-Rosch Biliary Z Stents™ (K921191, K903858, K882610) for intended use and design. Classification Class ll, 21CFR 876.5010, Biliary Catheters and Accessories. Performance Standard…	Cook, Inc.	1989	—

Also cleared against K905720: 9 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K980653	Perflex Stainless Steel Stent and Delivery System	Cordis Corp.	1998	7

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?

None of the 9 ancestors has a recall.
Of its descendants, K980653 (Cordis Corp., 1998) has gone furthest, with 7 descendants of its own.
9 other devices also cite its predicate K905720.

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.

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?

The Cordis Biliary Stent intended use is to maintain patency of a bile duct which is obstructed from malignant neoplasms.

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/K955728 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955728: Cordis Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955728

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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