510(k) · Decided
DecidedRX Megalink SDS Biliary Stent System, Otw Megalink SDS 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 Oct 8, 1999 as substantially equivalent to K983075 (Guidant Corp., 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 8, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K911292 (1991). 17 ancestors in all, the oldest K885180 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 3 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 2 generations backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- 1 generation backK980653 Perflex Stainless Steel Stent and Delivery SystemCordis Corp. · 1998
- This deviceK992319 RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent…Guidant Corp. · 1999
- Descendant · cites it directly · 0 of its ownK060817 Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK053459 Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −3 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −2 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| −1 | K980653 | Perflex Stainless Steel Stent and Delivery System | Cordis Corp. | 1998 | — |
| 0 (this device) | K992319 | RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System | Guidant Corp. | 1999 | — |
| +1 | K060817 | Omnilink. 018 Biliary Stent System | Guidant Endovascular Solutions, Inc. | 2006 | — |
| +1 | K053459 | Omnilink .035 Biliary Stent System | Guidant Corporation | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K983075 | Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38Summary page 1…turcs of RX and OTW MEGALINK™ SDS Biliary Stent Systems are substantially equivalent with regard to these features in the predicate devices, the MEGALINK™ Biliary Stent (K983075), the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™… | 1999 |
| * | K911581 | Palmaz (TM) Balloon-Expandable Stent, ModificationSummary page 1…e features in the predicate devices, the MEGALINK™ Biliary Stent (K983075), the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653). Device Description: The… | 1991 |
| * | K980653 | Perflex Stainless Steel Stent and Delivery SystemSummary page 1…loon-expandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653). Device Description: The RX and OTW MEGALINK™ SDS Biliary Stent Systems are comprised of a balloon-expandabie stent pre-mounte… | 1998 |
What descends from it? (2)
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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 17 ancestors has 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 K983075.
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 and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of maligriant 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/K992319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992319: RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992319
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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