510(k) · Cleared

Cleared

Vascu-Guard

K942010510(k) TraditionalCleared Jul 7, 199473-day reviewClass II21 CFR 870.3470

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

Bio-Vascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Jul 7, 1994 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 55 devices in its family, counting itself, have a Class I recall. 54 later devices descend from it.

Decided: Jul 7, 1994
Review: 73 days
Class: Class II
Product code: DXZ
Recalls: None
Predicates: 0

54 later devices descend from it, 6 citing it directly. 2 of the 55 devices in this family, counting this one, have a Class I recall.

This deviceK942010 Vascu-GuardBio-Vascular, Inc. · 1994
Descendant · cites it directly · 31 of its ownK983602 CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998 · Recalled
Descendant · 2 generations on · 24 of its ownK040415 Peri-Strips Staple Line Reinforcement - Sleeve and Strip…Synovis Surgical Innovations · 2004 · Recalled
Descendant · cites it directly · 17 of its ownK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
Descendant · cites it directly · 12 of its ownK041736 Pfa PatchPeritec Biosciences, LLC · 2005
Descendant · 2 generations on · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

1997high 5 (2014) · low 0 (1999)2026

Class I recalls in this family

K142461 VASCU-GUARD Peripheral Vascular Patch2 generations on · 2014
K111064 Tigerpaw System II4 generations on · 2011

Most influential descendants

Showing 5 of 54 · See all

K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998 · cites it directly31descendants
K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Synovis Surgical Innovations · 2004 · 2 generations on24descendants
K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004 · cites it directly17descendants
K041736Pfa PatchPeritec Biosciences, LLC · 2005 · cites it directly12descendants
K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K942010	Vascu-Guard	Bio-Vascular, Inc.	1994	—
+1	K983602	CV Peri-Guard and Vascu-Guard	Bio-Vascular, Inc.	1998	3
+2	K040415	Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…	Synovis Surgical Innovations	2004	1
+1	K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	—
+1	K041736	Pfa Patch	Peritec Biosciences, LLC	2005	—
+2	K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2003	1	0
2004	4	0
2005	1	0
2007	2	0
2008	3	0
2009	1	0
2010	3	0
2011	3	1
2012	1	0
2013	1	0
2014	5	1
2015	1	0
2016	3	0
2017	3	0
2018	3	0
2019	4	0
2020	3	0
2021	2	0
2022	4	0
2023	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K942010, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K983602	CV Peri-Guard and Vascu-Guard	Bio-Vascular, Inc.	1998	31
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	17
K041736	Pfa Patch	Peritec Biosciences, LLC	2005	12
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
K963368	Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative…	Glycar, Inc.	1997	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
K111064Tigerpaw System IILaax, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K983602 (Bio-Vascular, Inc., 1998) has gone furthest, with 31 descendants of its own.

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	—

https://510kreport.com/device/K942010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942010: Vascu-Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942010

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026