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 Jan 9, 2024 as substantially equivalent to K062161 (W. L. Gore & Associates, Inc., 2006) after a 160-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Jan 9, 2024
- Review
- 160 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830806 (1983). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830806 Vascular Graft/Bifurcated/Fep-RingedW. L. Gore & Associates, Inc. · 1983
- 1 generation backK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · Recalled
- This deviceK232312 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240083 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830806 | Vascular Graft/Bifurcated/Fep-Ringed | W. L. Gore & Associates, Inc. | 1983 | — |
| −1 | K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | 2006 | 2 |
| 0 (this device) | K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 12.4 · 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 |
|---|---|---|---|
| * | K062161 | Gore Propaten Vascular GraftSummary page 4…ce Name: GORE® PROPATEN® Vascular Graft Classification Name: Vascular Graft Regulation: 21 CFR 870.3450 Classification: II Product Code: DSY, DYF Predicate Devices K062161, GORE® PROPATEN® Vascular Graft Device Description The GORE® PROPATEN® Vascular Graft is a synthetic graft made of an expanded… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240083 | GORE® PROPATEN® Vascular Graft | 2024 | 0 |
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 23.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K240083 (W. L. Gore & Associates, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062161.
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?
GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering 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/K232312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232312: 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/K232312
Report an extraction error
Are you the manufacturer?
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