510(k) · Cleared
ClearedGelweave Vascular Grafts
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 30, 2017 as substantially equivalent to K964665 (Carbomedics, Inc., 1997) and 3 other predicates after a 269-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jun 30, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- DSY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K952293 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK952293 Vascutek Gelweave Vascular GraftVascutek, Ltd. · 1995
- 1 generation backK964665 Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Carbomedics, Inc. · 1997
- This deviceK162794 Gelweave Vascular GraftsVascutek, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK241550 Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | 1995 | — |
| −1 | K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration) | Carbomedics, Inc. | 1997 | — |
| 0 (this device) | K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017 | — |
| +1 | K241550 | Gelweave™ Vascular Prostheses | Vascutek, Ltd. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)Summary page 9…hich equivalence is being claimed Vascutek are claiming equivalence to the following legally marketed devices: • Gelweave™ Vascular Grafts (Bifurcated Configuration); K964665 • Gelweave Valsalva™ Vascular Grafts; K013022 • Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaqu… | 1997 |
| * | K013022 | Sulzer Vascutek Gelweave Valsalva Vascular ProsthesisSummary page 9…aiming equivalence to the following legally marketed devices: • Gelweave™ Vascular Grafts (Bifurcated Configuration); K964665 • Gelweave Valsalva™ Vascular Grafts; K013022 • Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers; K060142 • Gelweave™ Branche… | 2002 |
| * | K060142 | Vascutek Gelweave Siena Collared Anteflo and Plexus with Radiopaque MarkersSummary page 9…nfiguration); K964665 • Gelweave Valsalva™ Vascular Grafts; K013022 • Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers; K060142 • Gelweave™ Branched Vascular Grafts with Radiopaque Markers; K093817 Device Description Gelweave™ vascular prostheses are ge… | 2006 |
| * | K093817 | Gelweave Branched Vascular Grafts with Radiopaque MarkersSummary page 9…• Gelweave Siena™ Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers; K060142 • Gelweave™ Branched Vascular Grafts with Radiopaque Markers; K093817 Device Description Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair. The V… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241550 | Gelweave™ Vascular Prostheses | 2025 | 0 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 20.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K241550 (Vascutek, Ltd., 2025) has gone furthest, with 0 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. 2017, 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?
Indicated for thoracic reconstruction procedures for replacement of diseased segments of the thoracic aorta in cases of aneurysm, dissection, or coarctation. Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease. Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. Indicated for repair or replacement of…
Read the full statement (126 words)
Indicated for thoracic reconstruction procedures for replacement of diseased segments of the thoracic aorta in cases of aneurysm, dissection, or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.
Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.
Gelweave branched vascular prostheses, including Siena™ vascular prostheses 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/K162794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162794: Gelweave Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162794
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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