510(k) · Decided
DecidedMedtronic Ave Bridge Aurora Biliary Stent System (Aurora)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Ave, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 30, 2003 as substantially equivalent to K022026 (Medtronic Ave, Inc., 2002) after a 74-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 30, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011080 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK011080 Bridge SE Self-Expanding Stent Delivery SystemMedtronic Ave, Inc. · 2001
- 2 generations backK014205 Modification to Bridge Self-Expanding Biliary Stent Delivery System…Medtronic Ave, Inc. · 2002
- 1 generation backK022026 Medtronic Ave Bridge Polaris Biliary Stent System (Polaris)Medtronic Ave, Inc. · 2002
- This deviceK030839 Medtronic Ave Bridge Aurora Biliary Stent System (Aurora)Medtronic Ave, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011080 | Bridge SE Self-Expanding Stent Delivery System | Medtronic Ave, Inc. | 2001 | — |
| −2 | K014205 | Modification to Bridge Self-Expanding Biliary Stent Delivery System (Bridge SE) | Medtronic Ave, Inc. | 2002 | — |
| −1 | K022026 | Medtronic Ave Bridge Polaris Biliary Stent System (Polaris) | Medtronic Ave, Inc. | 2002 | — |
| 0 (this device) | K030839 | Medtronic Ave Bridge Aurora Biliary Stent System (Aurora) | Medtronic Ave, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K022026 | Medtronic Ave Bridge Polaris Biliary Stent System (Polaris)Summary page 1…Class I1 Classification Classification Panel: 78FGE Regulation Number: 21 C.F.R. $876.5010 Predicate Device Bridge Aurora (K022026) Performance Performance standards have not been est;iblishccl by the FDA under section Standards 514 of… | 2002 |
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 2 years and passes through 1 company; a new generation was cleared every 6 months on median.
- None of the 3 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.
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 Aurora Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030839: Medtronic Ave Bridge Aurora Biliary Stent System (Aurora).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030839
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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