510(k) · Decided
Recalled · 2008Lifestent Flexstart 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 Dec 21, 2005 as substantially equivalent to K024303 (Edwards Lifesciences, LLC, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 2001. 2 later devices descend from it. It has been recalled 103 times.
- Decided
- Dec 21, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 103
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010445 (2001). 8 ancestors in all, the oldest K971010 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
- 4 generations backK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001 · Recalled
- 3 generations backK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
- 2 generations backK024303 Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and…Edwards Lifesciences, LLC · 2003
- 1 generation backK042985 Lifestent NT35 Biliary Stent SystemEdwards Lifesciences, LLC · 2004
- This deviceK053404 Lifestent Flexstart Biliary Stent SystemEdwards Lifesciences, LLC · 2005
- Descendant · cites it directly · 1 of its ownK060487 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010445 | Precise Nitinol Stent Transhepatic Billary System | Cordis Corp. | 2001 | — |
| −4 | K012993 | Modification to Precise Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2001 | 1 |
| −3 | K021898 | Smart Control Nitinol Stent Transhepatic Biliary System | Cordis Corp. | 2002 | 1 |
| −2 | K024303 | Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery… | Edwards Lifesciences, LLC | 2003 | — |
| −1 | K042985 | Lifestent NT35 Biliary Stent System | Edwards Lifesciences, LLC | 2004 | — |
| 0 (this device) | K053404 | Lifestent Flexstart Biliary Stent System | Edwards Lifesciences, LLC | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K024303 | Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemSummary page 1…mon Name: Biliary Stent 6. Device Classification Name: Biliary Catheter (18 FOE), Class 11 7. Predicate Devices: LifeStent NT18 Self-Expanding Biliary Stent System (K024303) and LifeStent NT35 Self-Expanding Biliary Stent System (K(042985). Edwards Lifesciences Special 510(k) for the LifeStent Fle… | 2003 |
| * | K042985 | Lifestent NT35 Biliary Stent SystemSummary page 1…atheter (18 FOE), Class 11 7. Predicate Devices: LifeStent NT18 Self-Expanding Biliary Stent System (K024303) and LifeStent NT35 Self-Expanding Biliary Stent System (K(042985). Edwards Lifesciences Special 510(k) for the LifeStent FlexStar Biliary Stent System… | 2004 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2008 | Not classified | Z-0043-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0064-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0071-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0066-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0037-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0058-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0082-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0077-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0075-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0038-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0059-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0048-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0049-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0070-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0072-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0054-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0063-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0085-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0055-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0073-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0081-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0083-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0056-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0046-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0040-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0057-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0050-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0047-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0060-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0068-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0035-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0051-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0042-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0045-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0052-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0061-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0080-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0074-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0084-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0067-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0062-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0039-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0069-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0076-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0079-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0036-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0041-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0065-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0044-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
| Aug 29, 2008 | Not classified | Z-0053-2009 | Process control | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K060487 (Edwards Lifesciences, LLC, 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K024303.
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
2007high 11 (2008) · low 1 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
2007high 316 (2007) · low 49 (2016)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
2007high 93 (2008) · low 0 (2014)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
2007high 2,297 (2021) · low 1,006 (2007)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 Edwards Lifesciences LifeStent FlexStar 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/K053404 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053404: Lifestent Flexstart Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053404
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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