510(k) · Cleared
ClearedEptfe Vascular Prosthesis; Sealptfe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutek, Ltd. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Apr 9, 2003 after a 9-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 9, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK030999 Eptfe Vascular Prosthesis; SealptfeVascutek, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK130215 Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK231505 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK233551 GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K130215Gore Acuseal Vascular GraftW. L. Gore & Associates, Inc. · 2013 · cites it directly2descendants
- K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc. · 2023 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K030999 | Eptfe Vascular Prosthesis; Sealptfe | Vascutek, Ltd. | 2003 | — |
| +1 | K130215 | Gore Acuseal Vascular Graft | W. L. Gore & Associates, Inc. | 2013 | — |
| +2 | K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | — |
| +3 | K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130215 | Gore Acuseal Vascular Graft | 2013 | 2 |
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, K130215 (W. L. Gore & Associates, Inc., 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
The ePTFE vascular prosthesis is intended for:
CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030999: Eptfe Vascular Prosthesis; Sealptfe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030999
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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