510(k) · Decided
Recalled · 2008Bard E Luminexx Biliary Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 30, 2008 as substantially equivalent to K033497 (C.R. Bard, Inc., 2004) after a 555-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it. It has been recalled 17 times.
- Decided
- May 30, 2008
- Review
- 555 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 17
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020682 (2002). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK020682 Bard Luminexx 6 FR Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2002
- 1 generation backK033497 Bard Luminexx 3 Biliary Stent and Delivery SystemC.R. Bard, Inc. · 2004 · Recalled
- This deviceK063532 Bard E Luminexx Biliary StentBard Peripheral Vascular, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK093893 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2010 · Recalled
- Descendant · cites it directly · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK122546 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK130792 Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK130591 Supera VeritasIdev Technologies, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
2010high 2 (2012) · low 0 (2014)2026
Most influential descendants
Showing 5 of 6 · See all- K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2010 · cites it directly4descendants
- K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · cites it directly2descendants
- K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 2 generations on1descendant
- K130792Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc. · 2013 · cites it directly0descendants
- K130591Supera VeritasIdev Technologies, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020682 | Bard Luminexx 6 FR Biliary Stent and Delivery System | C.R. Bard, Inc. | 2002 | — |
| −1 | K033497 | Bard Luminexx 3 Biliary Stent and Delivery System | C.R. Bard, Inc. | 2004 | 1 |
| 0 (this device) | K063532 | Bard E Luminexx Biliary Stent | Bard Peripheral Vascular, Inc. | 2008 | — |
| +1 | K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2010 | 1 |
| +1 | K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary… | Idev Technologies, Inc. | 2011 | 1 |
| +2 | K122546 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary… | Idev Technologies, Inc. | 2012 | — |
| +1 | K130792 | Lifestent Biliary Stent System, Lifestent XL Biliary Stent System | C.R. Bard, Inc. | 2013 | — |
| +3 | K130591 | Supera Veritas | Idev Technologies, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K033497 | Bard Luminexx 3 Biliary Stent and Delivery SystemSummary page 1…ry Stent Classification: Class II Classification Panel: Gastroenterology/Urology Devices Panel Predicate Device: LUMINEXX® 3 Biliary Stent (K033497 on February 4, 2004) Summary of Change: The modification to the EOLUMINEXXTM Biliary Stent is an electropolished surface finish… | 2004 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System | 2010 | 4 |
| K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems | 2011 | 2 |
| K130792 | Lifestent Biliary Stent System, Lifestent XL Biliary Stent System | 2013 | 0 |
| K111627 | Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2008 | Not classified | Z-1466-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1454-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1468-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1467-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1463-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1459-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1469-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1460-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1456-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1457-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1462-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1455-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1464-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1458-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1453-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1465-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
| Dec 23, 2008 | Not classified | Z-1461-2009 | Employee error | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K093893 (Idev Technologies, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K033497.
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. 2008, 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?
The proposed device is indicated for the treatment of biliary strictures resulting from malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063532: Bard E Luminexx 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/K063532
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