510(k) · Cleared
ClearedGore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Oct 26, 2001 after a 28-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK013250 Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular GraftW. L. Gore & Associates, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK202471 exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs · 2020
- Descendant · 2 generations on · 1 of its ownK221628 exGraft, exGraft CarbonPeca Labs · 2022
- Descendant · 3 generations on · 0 of its ownK233783 exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs · 2020 · cites it directly2descendants
- K221628exGraft, exGraft CarbonPeca Labs · 2022 · 2 generations on1descendant
- K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013250 | Gore-Tex Vascular Graft; Gore-Tex Stretch Vascular Graft | W. L. Gore & Associates, Inc. | 2001 | — |
| +1 | K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | 2020 | — |
| +2 | K221628 | exGraft, exGraft Carbon | Peca Labs | 2022 | — |
| +3 | K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 12.5 · 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? (2)
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 |
|---|---|---|---|
| * | — | GORE-TEX® Vascular Grafts Named without a submission number | |
| * | — | GORE-TEX® Stretch 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 |
|---|---|---|---|
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | 2020 | 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, K202471 (Peca Labs, 2020) 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.
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?
GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, or for other vascular procedures.
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/K013250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013250: Gore-Tex Vascular Graft; Gore-Tex Stretch 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/K013250
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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