510(k) · Cleared
Recalled · Class II · 2021Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Carbomedics, Inc. · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cleared on Jun 13, 2002 as substantially equivalent to K952293 (Vascutek, Ltd., 1995) after a 279-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2002
- Review
- 279 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952293 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- This deviceK013022 Sulzer Vascutek Gelweave Valsalva Vascular ProsthesisSulzer Carbomedics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK162794 Gelweave Vascular GraftsVascutek, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK241550 Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | 1995 | — |
| 0 (this device) | K013022 | Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis | Sulzer Carbomedics, Inc. | 2002 | — |
| +1 | K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017 | — |
| +2 | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K952293 | Vascutek Gelweave Vascular GraftSummary page 1…ion, the Sulcer Vascutek Gelweave ValsalvaT" Vascular Prosthesis was compared to the followiiig predicate devices: + Sulzer Vascutek GelweaveTMVascular Prosthesis: K952293 (Straight) Testing: In vitro testing which evaluated Base Graft Water Porosity, Blood Porosity, Burst Strength, Tensile Strength… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162794 | Gelweave Vascular Grafts | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2021 | Class II | Z-2542-2021 | Under Investigation by firm | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
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?
The Sulzer VascutekO Gelweave Valsalva'" Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013022: Sulzer Vascutek Gelweave Valsalva Vascular Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013022
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026