510(k) · Decided
DecidedXpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Apr 7, 2004 as substantially equivalent to K033537 (Abbott Laboratories, 2003) after a 23-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Apr 7, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964688 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK964688 Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp. · 1997
- 2 generations backK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
- 1 generation backK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
- This deviceK040667 Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008…Abbott Laboratories · 2004
- Descendant · cites it directly · 0 of its ownK050534 Xpert Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005
Most influential descendants
Showing 1 of 1 · See all- K050534Xpert Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964688 | Long Medium Palmaz-Schatz Balloon Expandable Stent | Cordis Corp. | 1997 | — |
| −2 | K030053 | Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808… | Jomed AG | 2003 | — |
| −1 | K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006… | Abbott Laboratories | 2003 | — |
| 0 (this device) | K040667 | Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006… | Abbott Laboratories | 2004 | — |
| +1 | K050534 | Xpert Self-Expanding Transhepatic Biliary Stent System | Abbott Laboratories | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 |
|---|---|---|---|
| * | K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Summary page 1…21 CFR 876.5010 Classification Name: Biliary Catheter and Accessories Product Code: 78 FGE Predicate Device: Xpert TM Biliary Stent (K033537) Intended Use: The XpertTM Biliary Stent is intended for use in the palliation of malignant… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050534 | Xpert Self-Expanding Transhepatic Biliary Stent System | 2005 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K050534 (Abbott Laboratories, 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K033537.
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.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 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 Abbott Vascular Devices XpertTM Self-Expanding Transhepatic Biliary Stent System is intended
for use in the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040667 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040667: Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040667
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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