510(k) · Cleared
ClearedExxcel Soft Eptee Vascular Graft-Standard Wall,Thin Wall
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Jan 17, 2012 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 17, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK113101 Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin WallBoston Scientific Corporation · 2012
- Descendant · cites it directly · 2 of its ownK131778 Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK252445 Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK153523 FUSION Vascular GraftMaquet Cardiovascular, LLC · 2016
Most influential descendants
Showing 3 of 3 · See all- K131778Fusion Vascular Graft and Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2013 · cites it directly2descendants
- K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026 · 2 generations on0descendants
- K153523FUSION Vascular GraftMaquet Cardiovascular, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113101 | Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin Wall | Boston Scientific Corporation | 2012 | — |
| +1 | K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2013 | 1 |
| +2 | K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026 | — |
| +2 | K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 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 |
|---|---|---|---|
| * | — | EXXCEL Soft ePTFE Vascular Grafts Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131778 | Fusion Vascular Graft and Fusion Bioline Vascular Graft | 2013 | 2 |
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, K131778 (Maquet Cardiovascular, LLC, 2013) has gone furthest, with 2 descendants of its own.
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. 2012, 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?
Standard Wall EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access.
Thin Wall Exxcel Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113101: Exxcel Soft Eptee Vascular Graft-Standard Wall,Thin Wall.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113101
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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