510(k) · Cleared
ClearedExpandable Biliary Stent Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schneider Intl., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 16, 1989 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 16, 1989
- Review
- 64 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK885180 Expandable Biliary Stent EndoprosthesisSchneider Intl., Ltd. · 1989
- Descendant · cites it directly · 8 of its ownK955728 Cordis Biliary StentCordis Corp. · 1996
- Descendant · cites it directly · 7 of its ownK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- Descendant · 2 generations on · 3 of its ownK991929 IntrastentIntratherapeutics, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK993904 Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K955728Cordis Biliary StentCordis Corp. · 1996 · cites it directly8descendants
- K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998 · cites it directly7descendants
- K991929IntrastentIntratherapeutics, Inc. · 1999 · 2 generations on3descendants
- K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp. · 1999 · 2 generations on2descendants
- K993904Intrastent Doublestrut LDIntratherapeutics, Inc. · 2000 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885180 | Expandable Biliary Stent Endoprosthesis | Schneider Intl., Ltd. | 1989 | — |
| +1 | K955728 | Cordis Biliary Stent | Cordis Corp. | 1996 | — |
| +1 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| +2 | K991929 | Intrastent | Intratherapeutics, Inc. | 1999 | — |
| +2 | K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System | Guidant Corp. | 1999 | — |
| +3 | K993904 | Intrastent Doublestrut LD | Intratherapeutics, Inc. | 2000 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K955728 (Cordis Corp., 1996) has gone furthest, with 8 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 | — |
https://510kreport.com/device/K885180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K885180: Expandable Biliary Stent Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K885180
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026