510(k) · Decided
DecidedXpert Self-Expanding Transhepatic Biliary Stent System
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 May 20, 2005 as substantially equivalent to K040667 (Abbott Laboratories, 2004) after a 79-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- May 20, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964688 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964688 Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp. · 1997
- 3 generations backK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
- 2 generations backK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
- 1 generation backK040667 Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008…Abbott Laboratories · 2004
- This deviceK050534 Xpert Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964688 | Long Medium Palmaz-Schatz Balloon Expandable Stent | Cordis Corp. | 1997 | — |
| −3 | K030053 | Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808… | Jomed AG | 2003 | — |
| −2 | K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006… | Abbott Laboratories | 2003 | — |
| −1 | K040667 | Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006… | Abbott Laboratories | 2004 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K040667 | Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…Summary page 1…21 CFR 876.5010 Classification Name: Biliary Catheter and Accessories Product Code: 78 FGE Predicate Device: XpertTM Biliary Stent (K040667) Intended Use: The XpertT M Biliary Stent is intended for use in the palliation of malignant… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 7 ancestors has a recall.
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 Xpert TM Self-Expanding Transhepatic Biliary Stent System is indicated for use in the palliation
of malignant strictures (neoplasms) in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050534: Xpert Self-Expanding Transhepatic Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050534
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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