510(k) · Cleared
ClearedLifestent Flexstar XL Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 23, 2006 as substantially equivalent to K053404 (Edwards Lifesciences, LLC, 2005) and 1 other predicate after a 27-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Mar 23, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010445 (2001). 10 ancestors in all, the oldest K971010 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
- 5 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
- 4 generations backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
- 3 generations backK024303 Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and…Edwards Lifesciences, LLC · 2003
- 2 generations backK042985 Lifestent NT35 Biliary Stent SystemEdwards Lifesciences, LLC · 2004
- 1 generation backK053404 Lifestent Flexstart Biliary Stent SystemEdwards Lifesciences, LLC · 2005 · Recalled
- This deviceK060487 Lifestent Flexstar XL Biliary Stent SystemEdwards Lifesciences, LLC · 2006
- Descendant · cites it directly · 0 of its ownK130792 Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130792Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010445 | Precise Nitinol Stent Transhepatic Billary System | Cordis Corp. | 2001 | — |
| −5 | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2001 | 1 |
| −4 | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2002 | 1 |
| −3 | K024303 | Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery… | Edwards Lifesciences, LLC | 2003 | — |
| −2 | K042985 | Lifestent NT35 Biliary Stent System | Edwards Lifesciences, LLC | 2004 | — |
| −1 | K053404 | Lifestent Flexstart Biliary Stent System | Edwards Lifesciences, LLC | 2005 | 103 |
| 0 (this device) | K060487 | Lifestent Flexstar XL Biliary Stent System | Edwards Lifesciences, LLC | 2006 | — |
| +1 | K130792 | Lifestent Biliary Stent System, Lifestent XL Biliary Stent System | C.R. Bard, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K053404 | Lifestent Flexstart Biliary Stent SystemSummary page 1…Name: Biliary Stent 6.Device Classification Name: Biliary Catheter (78 FGE), Class II 7. Predicate Devices: LifeStent FlexStar Self-Expanding Biliary Stent System (K053404) ev3 Prot~gb OHS Self-Expanding Nitinol Stent (K(042204) Edwards Lifesciences Special 510(k) for the LifeStent FlexStar XL Bi… | 2005 |
| * | K042204 | Modification to Protege GPS Self-Expanding Nitinol StentSummary page 1…iary Catheter (78 FGE), Class II 7. Predicate Devices: LifeStent FlexStar Self-Expanding Biliary Stent System (K053404) ev3 Prot~gb OHS Self-Expanding Nitinol Stent (K(042204) Edwards Lifesciences Special 510(k) for the LifeStent FlexStar XL Biliary Stent System… | 2004 |
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 |
|---|---|---|---|
| K130792 | Lifestent Biliary Stent System, Lifestent XL Biliary Stent System | 2013 | 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 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K130792 (C.R. Bard, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K053404.
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 LifeStent FlexStar XL 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/K060487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060487: Lifestent Flexstar XL 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/K060487
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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