510(k) · Cleared
ClearedGlycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glycar, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Oct 31, 1997 as substantially equivalent to K942010 (Bio-Vascular, Inc., 1994) after a 430-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 31, 1997
- Review
- 430 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942010 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK942010 Vascu-GuardBio-Vascular, Inc. · 1994
- This deviceK963368 Glycartissue Repair Patch Family of Products; Glycar Vascular Repair…Glycar, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942010 | Vascu-Guard | Bio-Vascular, Inc. | 1994 | — |
| 0 (this device) | K963368 | Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch… | Glycar, Inc. | 1997 | — |
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
- #2 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 |
|---|---|---|---|
| * | K942010 | Vascu-GuardSummary page 1…ry name possible b) Common Name Biological Tissue Patch 4, F vice Classification Class II Device S, Predicate Device The predicate device is the Vascu-Guard™ product (K942010, and is a tissue patch made from glutaraldehyde-treated bovine pericardium. The device is produced by Bio-Vascular Inc., 2670 Pat… | 1994 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K942010.
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.
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?
The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963368: Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963368
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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