510(k) · Cleared
Recalled · Class II · 2025GORE® ACUSEAL 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 19, 2023 as substantially equivalent to K231505 (W. L. Gore & Associates, Inc., 2023) after a 46-day review. Its family tree reaches back 4 generations to 1983. It has been recalled once.
- Decided
- Dec 19, 2023
- Review
- 46 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830806 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830806 Vascular Graft/Bifurcated/Fep-RingedW. L. Gore & Associates, Inc. · 1983
- 3 generations backK062161 Gore Propaten Vascular GraftW. L. Gore & Associates, Inc. · 2006 · Recalled
- 2 generations backK130215 Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013
- 1 generation backK231505 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023
- This deviceK233551 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830806 | Vascular Graft/Bifurcated/Fep-Ringed | W. L. Gore & Associates, Inc. | 1983 | — |
| −3 | K062161 | Gore Propaten Vascular Graft | W. L. Gore & Associates, Inc. | 2006 | 2 |
| −2 | K130215 | Gore Acuseal Vascular Graft | W. L. Gore & Associates, Inc. | 2013 | — |
| −1 | K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | — |
| 0 (this device) | K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K231505 | GORE® ACUSEAL Vascular GraftSummary page 4…n Device Name: GORE® ACUSEAL Vascular Graft Classification Name: Vascular Graft Regulation: 21 CFR 870.3450 Classification: II Product Code: DSY Predicate Devices K231505, GORE® ACUSEAL Vascular Graft Device Description The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded poly… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2025 | Class II | Z-0036-2026 | Unknown/Undetermined by firm | Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
- 1 of the 7 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. 2023, 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® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233551: GORE® ACUSEAL 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/K233551
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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