510(k) · Cleared
ClearedGORE® PROPATEN® 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 Mar 1, 2024 as substantially equivalent to K232312 (W. L. Gore & Associates, Inc., 2024) after a 50-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Mar 1, 2024
- Review
- 50 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830806 (1983). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK830806 Vascular Graft/Bifurcated/Fep-RingedW. L. Gore & Associates, Inc. · 1983
- 2 generations backK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · Recalled
- 1 generation backK232312 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
- This deviceK240083 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830806 | Vascular Graft/Bifurcated/Fep-Ringed | W. L. Gore & Associates, Inc. | 1983 | — |
| −2 | K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | 2006 | 2 |
| −1 | K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
| 0 (this device) | K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 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 |
|---|---|---|---|
| * | K232312 | GORE® PROPATEN® Vascular GraftSummary page 4…Vascular Graft Classification Name: Vascular Graft Regulation: 21 CFR 870.3450 Classification: II Product Code: DSY, DYF Predicate Devices K232312, GORE® PROPATEN® Vascular Graft Device Description The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an e… | 2024 |
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 41 years and passes through 1 company; a new generation was cleared every 17.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2024, 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 GORE® PROPATEN® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering from occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240083: GORE® PROPATEN® 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/K240083
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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