510(k) · Decided
DecidedBridge FX
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 Aug 22, 2001 as substantially equivalent to K000744 (Medtronic Ave, Inc., 2000) and 2 other predicates after a 72-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Aug 22, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983008 (1998). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK983008 Peripheral Ave Stent SystemPeripheral Ave · 1998
- 1 generation backK992569 Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999
- This deviceK011817 Bridge FXMedtronic Ave, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK030633 Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK051785 Formula 418 Biliary StentCook, Inc. · 2005
- 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 ownK052539 Cook Formula 418 Biliary Stent SystemCook, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K030633Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003 · cites it directly2descendants
- K051785Formula 418 Biliary StentCook, Inc. · 2005 · cites it directly1descendant
- 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
- K052539Cook Formula 418 Biliary Stent SystemCook, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983008 | Peripheral Ave Stent System | Peripheral Ave | 1998 | — |
| −1 | K992569 | Medtronic Ave Bridge Stent | Medtronic Ave, Inc. | 1999 | — |
| 0 (this device) | K011817 | Bridge FX | Medtronic Ave, Inc. | 2001 | — |
| +1 | K030633 | Medtronic Ave Bridge Constant Biliary Stent System or ('Constant | Medtronic Ave, Inc. | 2003 | — |
| +1 | K051785 | Formula 418 Biliary Stent | Cook, Inc. | 2005 | — |
| +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 | K052539 | Cook Formula 418 Biliary Stent System | Cook, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 2 | 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? (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 |
|---|---|---|---|
| * | K000744 | Medtronic Ave Bridge X3 StentSummary page 1…ry Stent and Delivery System Biliary Catheter and Accessories Classification: Class II Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 e Bridge X3 (K000744, 6/5/00) ¢ Bridge Flexible/Hi-Flex (K992569, 8/31/99; K993145, 10/21/99) Performance standards have not been established by the… | 2000 |
| * | K992569 | Medtronic Ave Bridge StentSummary page 1…r and Accessories Classification: Class II Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 e Bridge X3 (K000744, 6/5/00) ¢ Bridge Flexible/Hi-Flex (K992569, 8/31/99; K993145, 10/21/99) Performance standards have not been established by the FDA under section 514 of the Federal, Food,… | 1999 |
| * | K993145 | Medtronic Ave Bridge StentSummary page 1…Classification: Class II Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 e Bridge X3 (K000744, 6/5/00) ¢ Bridge Flexible/Hi-Flex (K992569, 8/31/99; K993145, 10/21/99) Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic… | 1999 |
What descends from it? (5)
3 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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- 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™ FX Biliary Stent Delivery System is intended to maintain
patency of a bile 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/K011817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011817: Bridge FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011817
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026