510(k) · Decided

Decided

Bard Luminexx 6 FR Biliary Stent and Delivery System

K020682510(k) SpecialDecided Apr 2, 200229-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

C.R. Bard, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Apr 2, 2002 after a 29-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.

Decided: Apr 2, 2002
Review: 29 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 0

17 later devices descend from it, 3 citing it directly.

This deviceK020682 Bard Luminexx 6 FR Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2002
Descendant · cites it directly · 10 of its ownK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
Descendant · cites it directly · 9 of its ownK033497 Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004 · Recalled
Descendant · 2 generations on · 9 of its ownK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
Descendant · 2 generations on · 6 of its ownK063532 Bard E Luminexx Biliary StentBard Peripheral Vascular, Inc. · 2008 · Recalled
Descendant · 3 generations on · 6 of its ownK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003high 3 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 17 · See all

K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · cites it directly10descendants
K033497Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004 · cites it directly9descendants
K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · 2 generations on9descendants
K063532Bard E Luminexx Biliary StentBard Peripheral Vascular, Inc. · 2008 · 2 generations on6descendants
K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 2006 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K020682	Bard Luminexx 6 FR Biliary Stent and Delivery System	C.R. Bard, Inc.	2002	—
+1	K031777	Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System	Cordis Corp.	2003	3
+1	K033497	Bard Luminexx 3 Biliary Stent and Delivery System	C.R. Bard, Inc.	2004	1
+2	K032457	Modification to Smart Control Nitinol Stent Transhepatic Biliary System	Cordis Corp.	2003	—
+2	K063532	Bard E Luminexx Biliary Stent	Bard Peripheral Vascular, Inc.	2008	17
+3	K060557	Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…	Idev Technologies, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	2	0
2006	1	0
2008	3	0
2009	1	0
2010	1	0
2011	1	0
2012	3	0
2013	2	0

FIG. 1 — Lineage of K020682, 2002–2013Source: 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? (1)

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
*	—	Bard® LUMINEXX™ Biliary Stent and Delivery System Named without a submission number			—

What descends from it? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031777	Modeification to: Smart Control Nitinol Stent Transhepatic Biliary System	Cordis Corp.	2003	10
K033497	Bard Luminexx 3 Biliary Stent and Delivery System	C.R. Bard, Inc.	2004	9
K032137	Precise RX Nitinol Stent Transhepatic Biliary System	Cordis Corp.	2003	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?

Of its descendants, K031777 (Cordis Corp., 2003) has gone furthest, with 10 descendants of its own.

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 Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting 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/K020682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020682: Bard Luminexx 6 FR Biliary Stent and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020682

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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