510(k) · Cleared
Recalled · Class II · 2021Vascutek Branched Gelweave
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 Jun 19, 2009 as substantially equivalent to K952293 (Vascutek, Ltd., 1995) and 2 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Jun 19, 2009
- Review
- 73 days
- Class
- Class II
- Product code
- DSY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K952293 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- This deviceK090987 Vascutek Branched GelweaveVascutek, Ltd. · 2009
View 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) | K090987 | Vascutek Branched Gelweave | Vascutek, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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? (3)
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…www~vascutekcom 510(k) SUMMARY VASCUTEK GELWEAVETM BRANCHED VASCULAR GRAFTS (K952293) AND GELWEAVE SIENATM VASCULAR GRAFTS WITH (K060142) AND WITHOUT (K040829) RADIOPAQUE MARKERS… | 1995 |
| * | K040829 | Gelweave Ante-Flo with Collar and Gelweave 4 Branch Plexus with CollarSummary page 1…510(k) SUMMARY VASCUTEK GELWEAVETM BRANCHED VASCULAR GRAFTS (K952293) AND GELWEAVE SIENATM VASCULAR GRAFTS WITH (K060142) AND WITHOUT (K040829) RADIOPAQUE MARKERS Date prepared: 2 nd of June 2009 Prepared in accordance… | 2004 |
| * | K060142 | Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque MarkersSummary page 1…~vascutekcom 510(k) SUMMARY VASCUTEK GELWEAVETM BRANCHED VASCULAR GRAFTS (K952293) AND GELWEAVE SIENATM VASCULAR GRAFTS WITH (K060142) AND WITHOUT (K040829) RADIOPAQUE MARKERS Date prepared: 2 nd of June 2009… | 2006 |
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 |
|---|---|---|---|---|
| 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?
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K952293.
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. 2009, 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 branched vascular grafts:
“Repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation”.
Gelweave Siena vascular grafts with and without radiopaque markers:
“Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation”.
“Gelweave branched vascular grafts, including Siena grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procedures”.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090987: Vascutek Branched Gelweave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090987
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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