510(k) · Decided
DecidedLifestent LP 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 Jun 24, 2004 as substantially equivalent to K023121 (Orbus Medical Technologies, 2003) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 2003. 51 later devices descend from it.
- Decided
- Jun 24, 2004
- Review
- 31 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023248 (2003). 2 ancestors in all. 51 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023248 Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003 · Recalled
- This deviceK041370 Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
- Descendant · cites it directly · 50 of its ownK050627 Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005
- Descendant · 2 generations on · 47 of its ownK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
- Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
- Descendant · 5 generations on · 29 of its ownK112182 Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K050627Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005 · cites it directly50descendants
- K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005 · 2 generations on47descendants
- K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants
- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 4 generations on36descendants
- K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc. · 2011 · 5 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023248 | Lifestent LP SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2003 | 1 |
| 0 (this device) | K041370 | Lifestent LP SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2004 | — |
| +1 | K050627 | Lifestent Turbo Biliary Stent Systems | Edwards Lifesciences, LLC | 2005 | — |
| +2 | K052149 | Edwards Peripheral Dilation Catheter | Edwards Lifesciences, LLC | 2005 | — |
| +3 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| +4 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
| +5 | K112182 | Angiosculpt Pta Scoring Balloon Catheter | Angioscore, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K023121 | Lifestent Biliary EndoprosthesisSummary page 2…liary Endoprosthesis, comprised use, similar 7 mm LifeStent (K023 121) and the INVATEC catheter have the same intended methods, material properties, similar performance… | 2003 |
| * | K023248 | Lifestent LP SDS Biliary EndoprosthesisSummary page 2…previously cleared are a minor change to the predicate LifeStent LP SDS Biliary Endoprosthesis per K023248. Page 17 of 20 === Page… | 2003 |
What descends from it? (51)
See all 511 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050627 | Lifestent Turbo Biliary Stent Systems | 2005 | 50 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K050627 (Edwards Lifesciences, LLC, 2005) has gone furthest, with 50 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 Orbus LifeStent LP 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/K041370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041370: Lifestent LP SDS Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041370
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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