510(k) · Decided
DecidedModification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 22, 2003 as substantially equivalent to K031331 (Abbott Vascular, Inc., 2003) after a 30-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980823 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK980823 Cordis Nitinol Stent and Delivery SystemCordis Corp. · 1998
- 1 generation backK031331 WZ Self-Expanding Stent Transhepatic Biliary SystemAbbott Vascular, Inc. · 2003
- This deviceK032929 Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary…Abbott Vascular, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK050103 Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005
- Descendant · 2 generations on · 1 of its ownK050501 Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary…Abbott Vascular Devices · 2005
- Descendant · 3 generations on · 0 of its ownK072708 Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008
Most influential descendants
Showing 3 of 3 · See all- K050103Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories · 2005 · cites it directly2descendants
- K050501Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent SystemAbbott Vascular Devices · 2005 · 2 generations on1descendant
- K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980823 | Cordis Nitinol Stent and Delivery System | Cordis Corp. | 1998 | — |
| −1 | K031331 | WZ Self-Expanding Stent Transhepatic Biliary System | Abbott Vascular, Inc. | 2003 | — |
| 0 (this device) | K032929 | Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent… | Abbott Vascular, Inc. | 2003 | — |
| +1 | K050103 | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System | Abbott Laboratories | 2005 | — |
| +2 | K050501 | Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System | Abbott Vascular Devices | 2005 | — |
| +3 | K072708 | Absolute Pro .035 Self-Expanding Stent System | Abbott Vascular-Vascular Solutions | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K031331 | WZ Self-Expanding Stent Transhepatic Biliary SystemSummary page 1…Product Code: 78 FGE Predicate Device: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (K031331) Intended Use: The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent Sys… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050103 | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System | 2005 | 2 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050103 (Abbott Laboratories, 2005) has gone furthest, with 2 descendants of its own.
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 TM XceedTMNitinol 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/K032929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032929: Modification to:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032929
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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