510(k) · Cleared
ClearedFusion Bioline Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Cardiovascular, LLC · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Apr 27, 2026 as substantially equivalent to K131778 (Maquet Cardiovascular, LLC, 2013) after a 266-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Apr 27, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K791810 (1979). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK791810 Vascular Graft Prost. of Expanded PtfeImpra, Inc. · 1979
- 4 generations backK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- 3 generations backK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- 2 generations backK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- 1 generation backK131778 Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2013 · Recalled
- This deviceK252445 Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K791810 | Vascular Graft Prost. of Expanded Ptfe | Impra, Inc. | 1979 | — |
| −4 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| −3 | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| −2 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| −1 | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2013 | 1 |
| 0 (this device) | K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2012 | 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 DSY? 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 DSY device
- #1 K252277 Spiral Laminar Flow™ Vascular Arteriovenous…score 11.1 · 4 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 |
|---|---|---|---|
| * | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular GraftSummary page 5…to 21 CFR 870.3450 Legally Marketed Predicate Device(s) 510(k) Number Product Code Fusion Bioline Vascular Graft K131778 DSY Page 1 of 3 Fusion Bioline Perseus Project Traditional 510(k) K252445 Device… | 2013 |
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 47 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K131778.
How does its category compare?
All DSY devicesDSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSY
160in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSY
151in 2025
MAUDE reports naming product code DSY, 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 | 1 | — | 0 | 120 |
| 2008 | 1 | — | 0 | 164 |
| 2009 | 5 | 73 | 2 | 193 |
| 2010 | 4 | 55 | 5 | 187 |
| 2011 | 1 | — | 0 | 165 |
| 2012 | 4 | 30 | 0 | 177 |
| 2013 | 5 | 69 | 1 | 207 |
| 2014 | 2 | — | 0 | 352 |
| 2015 | 1 | — | 0 | 460 |
| 2016 | 1 | — | 2 | 217 |
| 2017 | 3 | 269 | 0 | 193 |
| 2018 | 1 | — | 0 | 200 |
| 2019 | 1 | — | 0 | 232 |
| 2020 | 1 | — | 0 | 169 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 155 |
| 2023 | 2 | — | 0 | 149 |
| 2024 | 5 | 160 | 0 | 153 |
| 2025 | 2 | — | 1 | 151 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Fusion Bioline Vascular Grafts are designed to repair or replace peripheral arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252445: Fusion Bioline Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252445
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026