510(k) · Decided

Recalled · 2005

Bard Luminexx 3 Biliary Stent and Delivery System

K033497510(k) SpecialDecided Feb 4, 200491-day reviewClass II21 CFR 876.5010Recalls 1

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 Feb 4, 2004 as substantially equivalent to K020682 (C.R. Bard, Inc., 2002) after a 91-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it. It has been recalled once.

Decided: Feb 4, 2004
Review: 91 days
Class: Class II
Product code: FGE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K020682 (2002). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK020682 Bard Luminexx 6 FR Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2002
This deviceK033497 Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004
Descendant · cites it directly · 6 of its ownK063532 Bard E Luminexx Biliary StentBard Peripheral Vascular, Inc. · 2008 · Recalled
Descendant · 2 generations on · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled
Descendant · 2 generations on · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled
Descendant · 3 generations on · 1 of its ownK122546 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2012
Descendant · cites it directly · 1 of its ownK082093 Bullseye Biliary Stent SystemSquareone · 2009

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 9 · See all

K063532Bard E Luminexx Biliary StentBard Peripheral Vascular, Inc. · 2008 · cites it directly6descendants
K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2010 · 2 generations on4descendants
K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · 2 generations on2descendants
K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 3 generations on1descendant
K082093Bullseye Biliary Stent SystemSquareone · 2009 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020682	Bard Luminexx 6 FR Biliary Stent and Delivery System	C.R. Bard, Inc.	2002	—
0 (this device)	K033497	Bard Luminexx 3 Biliary Stent and Delivery System	C.R. Bard, Inc.	2004	—
+1	K063532	Bard E Luminexx Biliary Stent	Bard Peripheral Vascular, Inc.	2008	17
+2	K093893	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…	Idev Technologies, Inc.	2010	1
+2	K111766	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary…	Idev Technologies, Inc.	2011	1
+3	K122546	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…	Idev Technologies, Inc.	2012	—
+1	K082093	Bullseye Biliary Stent System	Squareone	2009	—

Descendants by year cleared

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

FIG. 1 — Lineage of K033497, 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
*	K020682	Bard Luminexx 6 FR Biliary Stent and Delivery System Summary page 1 …Predicate Device Name(s): Bard®- LUMINEXX TM 6F Biliary Stent and Delivery System (K020682) D. Device Description: The Bard® LUMINEXX TM 3 Biliary Stent and Delivery System i…	C.R. Bard, Inc.	2002	—

Also cleared against K020682: 2 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K063532	Bard E Luminexx Biliary Stent	Bard Peripheral Vascular, Inc.	2008	6
K082093	Bullseye Biliary Stent System	Squareone	2009	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 21, 2005	Not classified	Z-1585-05	Other	Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K063532 (Bard Peripheral Vascular, Inc., 2008) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K020682.

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 TM 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033497: Bard Luminexx 3 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/K033497

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