510(k) · Decided
Recalled · 2009Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)
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 Oct 9, 2003 as substantially equivalent to K030633 (Medtronic Ave, Inc., 2003) after a 31-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 9, 2003
- Review
- 31 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983008 (1998). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK983008 Peripheral Ave Stent SystemPeripheral Ave · 1998
- 3 generations backK992569 Medtronic Ave Bridge StentMedtronic Ave, Inc. · 1999
- 2 generations backK011817 Bridge FXMedtronic Ave, Inc. · 2001
- 1 generation backK030633 Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantMedtronic Ave, Inc. · 2003
- This deviceK032768 Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)Medtronic Ave, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
Most influential descendants
Showing 1 of 1 · See all- K092352Scuba Biliary Stent SystemInvatec S.P.A. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983008 | Peripheral Ave Stent System | Peripheral Ave | 1998 | — |
| −3 | K992569 | Medtronic Ave Bridge Stent | Medtronic Ave, Inc. | 1999 | — |
| −2 | K011817 | Bridge FX | Medtronic Ave, Inc. | 2001 | — |
| −1 | K030633 | Medtronic Ave Bridge Constant Biliary Stent System or ('Constant | Medtronic Ave, Inc. | 2003 | — |
| 0 (this device) | K032768 | Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L) | Medtronic Ave, Inc. | 2003 | — |
| +1 | K092352 | Scuba Biliary Stent System | Invatec S.P.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030633 | Medtronic Ave Bridge Constant Biliary Stent System or ('ConstantSummary page 1…Classification Panel: 78FGE Regulation Number: 21 C.F.R. 9876.5010 Predicate Device Bridge Constant Biliary Stent System (K030633) (Previously named Bridge Symbiant) Performance Performance standards have not been established by… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092352 | Scuba Biliary Stent System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2009 | Not classified | Z-1802-2010 | Mixed-up of materials/components | Mislabeling-- The incorrect Instructions for use may have been included with this product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K092352 (Invatec S.P.A., 2010) has gone furthest, with 0 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, Inc. RACER 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/K032768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032768: Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032768
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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