510(k) · Decided
DecidedLifestent SDS and XL SDS Biliary Endoprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orbus Medical Technologies · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 16, 2004 as substantially equivalent to K023308 (Orbus Medical Technologies, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Mar 16, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941706 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK941706 Opti-Plast Angioplasty CatheterVas-Cath, Inc. · 1994
- 1 generation backK033212 Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
- This deviceK040550 Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
- Descendant · cites it directly · 0 of its ownK052132 Modification to: Lifestent Valeo Biliary Stent SystemEdwards Lifesciences, LLC · 2005
Most influential descendants
Showing 1 of 1 · See all- K052132Modification to: Lifestent Valeo Biliary Stent SystemEdwards Lifesciences, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941706 | Opti-Plast Angioplasty Catheter | Vas-Cath, Inc. | 1994 | — |
| −1 | K033212 | Lifestent SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2003 | — |
| 0 (this device) | K040550 | Lifestent SDS and XL SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2004 | — |
| +1 | K052132 | Modification to: Lifestent Valeo Biliary Stent System | Edwards Lifesciences, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K023308 | Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary EndoprosthesisSummary page 2…be considered substantially equivalent to the predicate devices previously cleared per K023308 and line extension to the LifeStent SDS Biliary Endoprosthesis K033212.… | 2003 |
| * | K033212 | Lifestent SDS Biliary EndoprosthesisSummary page 2…previously cleared per K023308 and line extension to the LifeStent SDS Biliary Endoprosthesis K033212. Page 17 of 20 === Page 3… | 2003 |
| † | K023121 | Lifestent Biliary Endoprosthesis | 2003 |
| † | K941706 | Opti-Plast Angioplasty Catheter | 1994 |
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 |
|---|---|---|---|
| K052132 | Modification to: Lifestent Valeo Biliary Stent System | 2005 | 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 10 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052132 (Edwards Lifesciences, LLC, 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023308.
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 Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040550 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040550
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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