510(k) · Cleared
Recalled · Class II · 2025Gelweave™ Vascular Prostheses
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 Feb 27, 2025 as substantially equivalent to K162794 (Vascutek, Ltd., 2017) after a 272-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Feb 27, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952293 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- 2 generations backK964665 Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
- 1 generation backK162794 Gelweave Vascular GraftsVascutek, Ltd. · 2017
- This deviceK241550 Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | 1995 | — |
| −2 | K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration) | Carbomedics, Inc. | 1997 | — |
| −1 | K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017 | — |
| 0 (this device) | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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 12.5 · 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 |
|---|---|---|---|
| * | K162794 | Gelweave Vascular GraftsSummary page 5…reater Diameter Regulation Number: 870.3450 Product Code(s): DSY LEGALLY MARKETED PREDICATE DEVICES Predicate #: K162794 Predicate Trade Name: Vascutek Gelweave™ Vascular Grafts Product Code: DSY DEVICE DESCRIPTION SUMMARY Gelw… | 2017 |
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 |
|---|---|---|---|---|
| Dec 18, 2025 | Class II | Z-1492-2026 | Error in labeling | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 6 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. 2025, 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?
Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair or replacement of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.
Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241550: Gelweave™ Vascular Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241550
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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