510(k) · Cleared
ClearedVascutek Gelweave Vascular Graft
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 Dec 19, 1995 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 19, 1995
- Review
- 217 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- Descendant · cites it directly · 2 of its ownK013022 Sulzer Vascutek Gelweave Valsalva Vascular ProsthesisSulzer Carbomedics, Inc. · 2002 · Recalled
- Descendant · cites it directly · 2 of its ownK964665 Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK162794 Gelweave Vascular GraftsVascutek, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK241550 Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK090987 Vascutek Branched GelweaveVascutek, Ltd. · 2009 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K013022Sulzer Vascutek Gelweave Valsalva Vascular ProsthesisSulzer Carbomedics, Inc. · 2002 · cites it directly2descendants
- K964665Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997 · cites it directly2descendants
- K162794Gelweave Vascular GraftsVascutek, Ltd. · 2017 · 2 generations on1descendant
- K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · 3 generations on0descendants
- K090987Vascutek Branched GelweaveVascutek, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | 1995 | — |
| +1 | K013022 | Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis | Sulzer Carbomedics, Inc. | 2002 | 1 |
| +1 | K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration) | Carbomedics, Inc. | 1997 | — |
| +2 | K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017 | — |
| +3 | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025 | 1 |
| +1 | K090987 | Vascutek Branched Gelweave | Vascutek, Ltd. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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? (6)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013022 (Sulzer Carbomedics, Inc., 2002) 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 | — |
https://510kreport.com/device/K952293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952293: Vascutek Gelweave Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952293
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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