510(k) · Cleared
ClearedGore-Tex Vasular 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 Aug 20, 1981 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Aug 20, 1981
- Review
- 85 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK811510 Gore-Tex Vasular GraftW. L. Gore & Associates, Inc. · 1981
- Descendant · cites it directly · 13 of its ownK955460 Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe…Meadox Medicals, Div. Boston Scientific Corp. · 1996
- Descendant · cites it directly · 12 of its ownK960766 Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- Descendant · 2 generations on · 12 of its ownK962433 Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997
- Descendant · 2 generations on · 11 of its ownK052964 Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour…Boston Scientific Corp · 2006 · Recalled
- Descendant · 3 generations on · 7 of its ownK071778 Hero Vascular Access DeviceGraftcath, Inc. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K955460Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · cites it directly13descendants
- K960766Meadox Medicals, Inc. Expanded Ptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · cites it directly12descendants
- K962433Meadox Exxcel Eptfe Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · 2 generations on12descendants
- K052964Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular…Boston Scientific Corp · 2006 · 2 generations on11descendants
- K071778Hero Vascular Access DeviceGraftcath, Inc. · 2008 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K811510 | Gore-Tex Vasular Graft | W. L. Gore & Associates, Inc. | 1981 | — |
| +1 | K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded Ptfe Vascular… | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| +1 | K960766 | Meadox Medicals, Inc. Expanded Ptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| +2 | K962433 | Meadox Exxcel Eptfe Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | — |
| +2 | K052964 | Exxcel and Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted… | Boston Scientific Corp | 2006 | 3 |
| +3 | K071778 | Hero Vascular Access Device | Graftcath, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 152 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955460 (Meadox Medicals, Div. Boston Scientific Corp., 1996) has gone furthest, with 13 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 | — |
https://510kreport.com/device/K811510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K811510: Gore-Tex Vasular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K811510
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026