510(k) · Decided
DecidedOmnilink. 018 Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Endovascular Solutions, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 15, 2006 as substantially equivalent to K992319 (Guidant Corp., 1999) and 2 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 15, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K911292 (1991). 22 ancestors in all, the oldest K885180 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 4 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 3 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 2 generations backK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- 1 generation backK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
- This deviceK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −4 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −3 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −2 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| −1 | K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System | Guidant Corp. | 1999 | — |
| 0 (this device) | K060817 | Omnilink. 018 Biliary Stent System | Guidant Endovascular Solutions, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemSummary page 1…t System, subject device of this 510(k), is substantially similar in materials, design and intended use to the predicate devices, OTW MEGALINK® SDS Biliary Stent System (K992319), and the OMNILINK® .018 Biliary Stent System (K011039 and K033834). The changes described herein involve optimized manufacturing… | 1999 |
| * | K011039 | Omnilink .018 Biliary Stent SystemSummary page 1…ly similar in materials, design and intended use to the predicate devices, OTW MEGALINK® SDS Biliary Stent System (K992319), and the OMNILINK® .018 Biliary Stent System (K011039 and K033834). The changes described herein involve optimized manufacturing parameters, revised test methods, addition of process… | 2001 |
| * | K033834 | Omnilink .018 Biliary Stent SystemSummary page 1…n materials, design and intended use to the predicate devices, OTW MEGALINK® SDS Biliary Stent System (K992319), and the OMNILINK® .018 Biliary Stent System (K011039 and K033834). The changes described herein involve optimized manufacturing parameters, revised test methods, addition of process monitoring,… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K992319.
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 Guidant OMNILINK® .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/K060817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060817: Omnilink. 018 Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060817
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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