510(k) · Decided
DecidedLifestent 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 10, 2003 after a 172-day review. The FDA summary names its predicate without a number. 52 later devices descend from it.
- Decided
- Mar 10, 2003
- Review
- 172 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 1 citing it directly.
- This deviceK023121 Lifestent Biliary EndoprosthesisOrbus Medical Technologies · 2003
- Descendant · cites it directly · 51 of its ownK041370 Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
- Descendant · 2 generations on · 50 of its ownK050627 Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005
- Descendant · 3 generations on · 47 of its ownK052149 Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005
- Descendant · 4 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004 · cites it directly51descendants
- K050627Lifestent Turbo Biliary Stent SystemsEdwards Lifesciences, LLC · 2005 · 2 generations on50descendants
- K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC · 2005 · 3 generations on47descendants
- K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 4 generations on44descendants
- K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023121 | Lifestent Biliary Endoprosthesis | Orbus Medical Technologies | 2003 | — |
| +1 | K041370 | Lifestent LP SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2004 | — |
| +2 | K050627 | Lifestent Turbo Biliary Stent Systems | Edwards Lifesciences, LLC | 2005 | — |
| +3 | K052149 | Edwards Peripheral Dilation Catheter | Edwards Lifesciences, LLC | 2005 | — |
| +4 | K083657 | Conquest Pta Balloon Dilatation Catheter | C.R. Bard, Inc. | 2008 | 2 |
| +5 | K103459 | Vascutrak Pta Dilatation Catheter | C.R. Bard, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | — | Orbus R Stent (LifeStent) Biliary Endoprosthesis Named without a submission number | |
| * | — | IntraTherapeutics Intrastent Biliary Endoprosthesis Named without a submission number | |
| * | — | IntraTherapeutics Intrastent Doublestrut Biliary Endoprosthesis Named without a submission number | |
| * | — | IntraTherapeutics Intrastent Doublestrut XS Biliary Endoprosthesis Named without a submission number | |
| * | — | Cordis Palmaz Balloon Expandable Stent Named without a submission number |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041370 | Lifestent LP SDS Biliary Endoprosthesis | 2004 | 51 |
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, K041370 (Orbus Medical Technologies, 2004) has gone furthest, with 51 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 Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023121: Lifestent 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/K023121
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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