510(k) · Decided
DecidedModification to RX Herculink Elite Biliary Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 14, 2007 as substantially equivalent to K053454 (Guidant Corporation, 2006) and 1 other predicate after a 301-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Sep 14, 2007
- Review
- 301 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K905720 (1991). 19 ancestors in all, the oldest K901406 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- 7 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
- 6 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
- 5 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
- 4 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
- 3 generations backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
- 2 generations backK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
- 1 generation backK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
- This deviceK063481 Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| −7 | K990631 | Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model… | Cordis Corp. | 1999 | — |
| −6 | K991028 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories | Cordis Corp. | 1999 | — |
| −5 | K992755 | Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System… | Cordis, A Johnson & Johnson Co. | 1999 | — |
| −4 | K994156 | Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models… | Cordis Corp. | 2000 | — |
| −3 | K012056 | Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2001 | — |
| −2 | K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2004 | — |
| −1 | K053454 | RX Herculink Elite Biliary Stent System | Guidant Corporation | 2006 | — |
| 0 (this device) | K063481 | Modification to RX Herculink Elite Biliary Stent System | Abbott Vascular, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K053454 | RX Herculink Elite Biliary Stent SystemSummary page 1…tial Equivalence: The modified RX Herculink Elite T M Biliary Stent System is substantially equivalent to the original RX Herculink Elite Biliary Stent System (K053454, cleared 3/6/2006) and RX Herculink Plus Biliary Stent System (K010684, cleared 4/12/2001). Changes made to the origina… | 2006 |
| * | K010684 | RX Herculink Plus Biliary Stent SystemSummary page 1…tem is substantially equivalent to the original RX Herculink Elite Biliary Stent System (K053454, cleared 3/6/2006) and RX Herculink Plus Biliary Stent System (K010684, cleared 4/12/2001). Changes made to the original RX Herculink Elite Biliary Stent System focused primarily on the delivery… | 2001 |
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 16 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 19 ancestors has a recall.
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. 2007, this device’s year, is highlighted.
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 RX Herculink®Elite™ 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/K063481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063481: Modification to RX Herculink Elite 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/K063481
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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