510(k) · Cleared

Recalled · Class I · 2025

Glycar Pericardial Patch

K963967510(k) TraditionalCleared Oct 31, 1997394-day reviewClass II21 CFR 870.3470Recalls 2 (2 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Glycar, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Oct 31, 1997 as substantially equivalent to K923657 (Bio-Vascular, Inc., 1992) after a 394-day review. Its family tree reaches back 1 generation to 1992. 1 of the 22 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.

Decided: Oct 31, 1997
Review: 394 days
Class: Class II
Product code: DXZ
Recalls: 2 (2 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K923657 (1992). 20 later devices descend from it, 3 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK923657 Supple Peri-GuardBio-Vascular, Inc. · 1992
This deviceK963967 Glycar Pericardial PatchGlycar, Inc. · 1997
Descendant · cites it directly · 17 of its ownK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
Descendant · 2 generations on · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
Descendant · 3 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
Descendant · cites it directly · 5 of its ownK082139 Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008
Descendant · 4 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2004high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 20 · See all

K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004 · cites it directly17descendants
K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · 2 generations on7descendants
K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 3 generations on5descendants
K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008 · cites it directly5descendants
K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923657	Supple Peri-Guard	Bio-Vascular, Inc.	1992	—
0 (this device)	K963967	Glycar Pericardial Patch	Glycar, Inc.	1997	—
+1	K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	—
+2	K090288	Orthadapt PR	Pegasus Biologics, Inc.	2009	—
+3	K112786	Proseries Bioimplants-Proankle/Procuff	Synovis Orthopedic and Woundcare, Inc.	2011	—
+1	K082139	Edwards Bovine Pericardial Patch, Model 4700	Edwards Lifesciences, LLC	2008	—
+4	K220091	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device	Xiros, Ltd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	1	0
2014	1	0
2016	1	0
2017	2	0
2019	1	0
2020	2	0
2022	1	0
2023	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K963967, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

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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	Applicant	Decided	Recalls
*	K923657	Supple Peri-Guard Summary page 1 …lassification Class III Device - we do not believe PMA is needed i vi The predicate device is the Tissue Guard™ product line, including Supple Peri-Guard™ product line (K923657), and is a tissue patch made from glutaraldehyde-treated bovine pericardium. The device is produced by Bio-Vascular Inc., 2670 Pa…	Bio-Vascular, Inc.	1992	—

Also cleared against K923657: 8 other devices →

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	17
K082139	Edwards Bovine Pericardial Patch, Model 4700	Edwards Lifesciences, LLC	2008	5
K033985	Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10	Pm Devices, Inc.	2004	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 9, 2025	Class I	Z-0532-2026	Process control	The impacted lot may not meet the required tensile strength specification.
Oct 9, 2025	Class I	Z-0531-2026	Process control	The impacted lot may not meet the required tensile strength specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K040835 (Pm Devices, Inc., 2004) has gone furthest, with 17 descendants of its own.
8 other devices also cite its predicate K923657.

How does its category compare?

All DXZ devices

DXZ 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

2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007high 171 (2015) · low 6 (2008)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/K963967 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963967: Glycar Pericardial Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963967

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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