510(k) · Cleared
ClearedGore-Tex (R) 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 Dec 6, 1990 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 6, 1990
- Review
- 104 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK903931 Gore-Tex (R) Stretch Vascular GraftW. L. Gore & Associates, Inc. · 1990
- Descendant · cites it directly · 7 of its ownK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · Recalled
- Descendant · cites it directly · 2 of its ownK130215 Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK232312 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK231505 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK240083 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062161Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · cites it directly7descendants
- K130215Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013 · cites it directly2descendants
- K232312GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024 · 2 generations on1descendant
- K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · 2 generations on1descendant
- K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, 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) | K903931 | Gore-Tex (R) Stretch Vascular Graft | W. L. Gore & Associates, Inc. | 1990 | — |
| +1 | K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | 2006 | 2 |
| +1 | K130215 | Gore Acuseal Vascular Graft | W. L. Gore & Associates, Inc. | 2013 | — |
| +2 | K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
| +2 | K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | — |
| +3 | K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K062161 (W. L. Gore & Associates, Inc., 2006) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K903931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903931: Gore-Tex (R) Stretch Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903931
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026