510(k) · Decided
DecidedLifestent 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 Oct 30, 2003 as substantially equivalent to K010107 (Orbus Medical Technologies, 2001) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 27 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K941706 (1994). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941706 Opti-Plast Angioplasty CatheterVas-Cath, Inc. · 1994
- This deviceK033212 Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
- Descendant · cites it directly · 1 of its ownK040550 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941706 | Opti-Plast Angioplasty Catheter | Vas-Cath, Inc. | 1994 | — |
| 0 (this device) | K033212 | Lifestent SDS Biliary Endoprosthesis | Orbus Medical Technologies | 2003 | — |
| +1 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K010107 | R Stent Biliary Endoprosthesis | 2001 |
| * | K941706 | Opti-Plast Angioplasty CatheterSummary page 2…Conclusion Since the [8 x 18 mm] LifeStent SDS Biliary Endoprosthesis, comprised of the 0 6-10 mm LifeStent (KO I O 107) and the Opti-Plast XT catheter (K94 1706), has the same intended use, identical material properties, similar performance properties, packaging, and sterilization… | 1994 |
| * | K023308 | Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary EndoprosthesisSummary page 2…tantially equivalent to the predicate devices cited in (7). These devices are a line extension to the LifeStent SDS Biliary Endoprosthesis previously cleared per K023308. Page 16 of 19… | 2003 |
| * | — | LifeStent SDS Biliary Endoprosthesis Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K040550 (Orbus Medical Technologies, 2004) has gone furthest, with 1 descendant 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 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/K033212 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033212: Lifestent 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/K033212
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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