510(k) · Cleared
Recalled · Class II · 2021Gore 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 Nov 9, 2006 as substantially equivalent to K830806 (W. L. Gore & Associates, Inc., 1983) and 2 other predicates after a 104-day review. Its family tree reaches back 1 generation to 1983. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 9, 2006
- Review
- 104 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K830806 (1983). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK830806 Vascular Graft/Bifurcated/Fep-RingedW. L. Gore & Associates, Inc. · 1983
- This deviceK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK130215 Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013
- Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK240083 GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK233551 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130215Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013 · cites it directly2descendants
- K232312GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024 · cites it directly1descendant
- K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · 2 generations on1descendant
- K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc. · 2024 · 2 generations on0descendants
- K233551GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830806 | Vascular Graft/Bifurcated/Fep-Ringed | W. L. Gore & Associates, Inc. | 1983 | — |
| 0 (this device) | K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | 2006 | — |
| +1 | K130215 | Gore Acuseal Vascular Graft | W. L. Gore & Associates, Inc. | 2013 | — |
| +1 | K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
| +2 | K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | — |
| +2 | K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024 | — |
| +3 | K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | 1 |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K830806 | Vascular Graft/Bifurcated/Fep-RingedSummary page 2…emovable Rings, which have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943. The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded po… | 1983 |
| * | K903931 | Gore-Tex (R) Stretch Vascular GraftSummary page 2…Rings, which have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943. The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded polytetrafl… | 1990 |
| * | K933943 | Fep Ringed Gore-Tex Stretch Vascualr Graft with Removable RingsSummary page 2…have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943. The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded polytetrafluoroethylene… | 1993 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2021 | Class II | Z-2292-2021 | Under Investigation by firm | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. |
| May 12, 2021 | Class II | Z-2293-2021 | Under Investigation by firm | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis 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/K062161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062161: Gore Propaten 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/K062161
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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