510(k) · Decided
DecidedRX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Cardiovascular Systems, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 2, 1999 as substantially equivalent to K911581 (Johnson & Johnson Interventional Systems, 1991) after a 170-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Sep 2, 1999
- Review
- 170 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911581 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK911581 Palmaz (TM) Balloon-Expandable Stent, ModificationJohnson & Johnson Interventional Systems · 1991
- This deviceK990867 RX Herculink 14 Biliary Stent System, Model…Advanced Cardiovascular Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK993588 Modification to RX Herculink 14 Biliary Stent System, Models…Guidant Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K993588Modification to RX Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13…Guidant Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911581 | Palmaz (TM) Balloon-Expandable Stent, Modification | Johnson & Johnson Interventional Systems | 1991 | — |
| 0 (this device) | K990867 | RX Herculink 14 Biliary Stent System, Model… | Advanced Cardiovascular Systems, Inc. | 1999 | — |
| +1 | K993588 | Modification to RX Herculink 14 Biliary Stent System, Models 1005126-13… | Guidant Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (1)
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 |
|---|---|---|---|
| * | K911581 | Palmaz (TM) Balloon-Expandable Stent, ModificationSummary page 1…tantially equivalent with regard to these features in the predicate device, the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581). Device Description: RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX… | 1991 |
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 |
|---|---|---|---|
| K993588 | Modification to RX Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13… | 1999 | 0 |
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?
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 RX Herculink™ 14 Biliary Stent System is indicated for the palliation of malignant
neoplasms in the biliary tree.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990867: RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990867
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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