510(k) · Decided
DecidedGuidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38
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 Mar 3, 1999 as substantially equivalent to K905720 (Johnson & Johnson Interventional Systems, 1991) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Mar 3, 1999
- Review
- 182 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905720 (1991). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
- This deviceK983075 Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28…Guidant Corp. · 1999
- Descendant · cites it directly · 2 of its ownK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK053459 Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006
- Descendant · cites it directly · 0 of its ownK991032 Guidant Megalink Biliary Stent, Model FG1002949-58Guidant Corp. · 1999
Most influential descendants
Showing 4 of 4 · See all- K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp. · 1999 · cites it directly2descendants
- K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006 · 2 generations on0descendants
- K053459Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006 · 2 generations on0descendants
- K991032Guidant Megalink Biliary Stent, Model FG1002949-58Guidant Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905720 | Palmaz Biliary Stent | Johnson & Johnson Interventional Systems | 1991 | — |
| 0 (this device) | K983075 | Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38 | Guidant Corp. | 1999 | — |
| +1 | K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System | Guidant Corp. | 1999 | — |
| +2 | K060817 | Omnilink. 018 Biliary Stent System | Guidant Endovascular Solutions, Inc. | 2006 | — |
| +2 | K053459 | Omnilink .035 Biliary Stent System | Guidant Corporation | 2006 | — |
| +1 | K991032 | Guidant Megalink Biliary Stent, Model FG1002949-58 | Guidant Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K905720 | Palmaz Biliary StentSummary page 1…LINK™ Biliary Stent are substantially equivalent with regard to these features in the predicate device, the JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581). Device Description: The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percu… | 1991 |
| * | K911581 | Palmaz (TM) Balloon-Expandable Stent, ModificationSummary page 1…y Stent are substantially equivalent with regard to these features in the predicate device, the JJIS PALMAZ™ balloon-expandable Stent for the Biliary System (K905720 and K911581). Device Description: The Guidant MEGALINK™ Biliary Stent is a balloon-expandable stent designed to be placed percutaneously in… | 1991 |
What descends from it? (4)
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?
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 MEGALINK™ Biliary Stent is indicated for the palliation of malignant
strictures 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/K983075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983075: Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983075
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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