510(k) · Cleared
ClearedXpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605
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 Oct 1, 2004 as substantially equivalent to K033909 (Abbott Laboratories, 2004) after a 72-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Oct 1, 2004
- Review
- 72 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K905720 (1991). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 7 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 6 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 5 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 4 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
- 3 generations backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- 2 generations backK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
- 1 generation backK033909 Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
- This deviceK041962 Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models…Abbott Laboratories · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −7 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −6 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −5 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −4 | K994156 | Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models… | Cordis Corp. | 2000 | — |
| −3 | K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2001 | — |
| −2 | K012590 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery… | Cordis Corp. | 2001 | — |
| −1 | K033909 | Wavemax Balloon-Expandable Transhepatic Biliary Stent System | Abbott Laboratories | 2004 | — |
| 0 (this device) | K041962 | Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587… | Abbott Laboratories | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K033909 | Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemSummary page 1…0 Classification Name: Biliary Catheter and Accessories Product Code: 78 FGE Predicate Device: wavemaXTM Transhepatic Biliary Stent (K033909) Intended Use: The XpandTM Balloon-Expandable Transhepatic Biliary Stent System… | 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 13 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- None of the 20 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 Abbott Vascular Devices XpandTM Balloon-Expandable 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/K041962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041962: Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041962
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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