510(k) · Decided
Recalled · 2005Omnilink .018 Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jan 2, 2004 as substantially equivalent to K011039 (Guidant Corp., 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 2, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011506 (2001). 3 ancestors in all, the oldest K011039 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011506 Omnilink .035 Biliary Stent SystemGuidant Corp. · 2001 · Recalled
- 1 generation backK032530 Modification to Omnilink .035 Biliary Stent SystemGuidant Corporation · 2003 · Recalled
- This deviceK033834 Omnilink .018 Biliary Stent SystemGuidant Corp. · 2004
- Descendant · cites it directly · 0 of its ownK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011506 | Omnilink .035 Biliary Stent System | Guidant Corp. | 2001 | 1 |
| −1 | K032530 | Modification to Omnilink .035 Biliary Stent System | Guidant Corporation | 2003 | 1 |
| 0 (this device) | K033834 | Omnilink .018 Biliary Stent System | Guidant Corp. | 2004 | — |
| +1 | K060817 | Omnilink. 018 Biliary Stent System | Guidant Endovascular Solutions, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K011039 | Omnilink .018 Biliary Stent SystemSummary page 1…d intended use features of the subject device are substantial equivalent with regard to these features in the predicate devices, the OMNILINK® .018 Biliary Stent System (K011039, cleared May 8, 2001) and the OMNILINK® .035 Biliary Stent System (K032530, cleared October 23, 2003). The new sizes will be mark… | 2001 |
| * | K032530 | Modification to Omnilink .035 Biliary Stent SystemSummary page 1…th regard to these features in the predicate devices, the OMNILINK® .018 Biliary Stent System (K011039, cleared May 8, 2001) and the OMNILINK® .035 Biliary Stent System (K032530, cleared October 23, 2003). The new sizes will be marketed as part of the OMNILINK® .018 Biliary Stent System product line. Dev… | 2003 |
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 |
|---|---|---|---|
| K060817 | Omnilink. 018 Biliary Stent System | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2005 | Not classified | Z-1586-05 | Other | This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K060817 (Guidant Endovascular Solutions, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K011039.
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 ON4NILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033834: Omnilink .018 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/K033834
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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