510(k) · Cleared
ClearedVascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutek, Ltd. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Jul 8, 2020 as substantially equivalent to K963611 (Vascutek, Ltd., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jul 8, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931386 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 1 generation backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- This deviceK200955 Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall…Vascutek, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −1 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| 0 (this device) | K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | 2020 | — |
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 DXZ? 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 DXZ device
- #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek…Summary page 5…lence is being claimed: Vascutek Ltd. are claiming equivalence to the following legally marketed devices: Vascutek Cardiovascular Fabric: x Vascutek GelsealTM Patch (K963611) x Vascutek GelsoftTM Patch (K963611) x Vascutek Thin Wall Carotid Patch (K963611) Device Description The Vascutek Cardi… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 2 companies; a new generation was cleared every 23.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K963611.
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 2025
MAUDE reports naming product code DXZ, 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 | 50 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 109 |
| 2010 | 3 | 91 | 2 | 81 |
| 2011 | 2 | — | 2 | 47 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 1 | — | 2 | 69 |
| 2014 | 3 | 106 | 0 | 93 |
| 2015 | 2 | — | 0 | 171 |
| 2016 | 2 | — | 0 | 66 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 1 | 44 |
| 2019 | 0 | — | 0 | 55 |
| 2020 | 1 | — | 1 | 121 |
| 2021 | 0 | — | 0 | 80 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 2 | 40 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 1 | — | 2 (2) | 119 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Vascutek Cardiovascular Fabric is indicated for vascular or cardiovascular repair whenever knitted polyester fabrics are
normally indicated.
Due to its particularly high strength, Gelseal is especially suitable for thoracic use whereas the softer handle of the Gelsoft
makes it ideal for peripheral use. The Thin Wall fabric is designed for patch closure after endarterectomy, particularly of
the carotid arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200955: Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200955
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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