510(k) · Decided
DecidedMedtronic Ave Stent Delivery System - for Use in Biliary Indication
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peripheral Ave · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 29, 1999 after an 87-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 29, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK991533 Medtronic Ave Stent Delivery System - for Use in Biliary IndicationPeripheral Ave · 1999
- Descendant · cites it directly · 2 of its ownK030633 Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK032768 Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)Medtronic Ave, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
- Descendant · cites it directly · 0 of its ownK061235 Lifestent Turbo Biliary Stent SystemEdwards Lifesciences, LLC · 2006
Most influential descendants
Showing 4 of 4 · See all- K030633Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003 · cites it directly2descendants
- K032768Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)Medtronic Ave, Inc. · 2003 · 2 generations on1descendant
- K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010 · 3 generations on0descendants
- K061235Lifestent Turbo Biliary Stent SystemEdwards Lifesciences, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991533 | Medtronic Ave Stent Delivery System - for Use in Biliary Indication | Peripheral Ave | 1999 | — |
| +1 | K030633 | Medtronic Ave Bridge Constant Biliary Stent System or ('Constant | Medtronic Ave, Inc. | 2003 | — |
| +2 | K032768 | Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L) | Medtronic Ave, Inc. | 2003 | 1 |
| +3 | K092352 | Scuba Biliary Stent System | Invatec S.P.A. | 2010 | — |
| +1 | K061235 | Lifestent Turbo Biliary Stent System | Edwards Lifesciences, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | — | Peripheral AVE Stent Delivery System - For Use In Biliary Indication Named without a submission number |
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?
- Of its descendants, K030633 (Medtronic Ave, Inc., 2003) has gone furthest, with 2 descendants of its own.
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 Medtronic AVE Bridge™ Stent System — Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor
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/K991533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991533: Medtronic Ave Stent Delivery System - for Use in Biliary Indication.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991533
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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