510(k) · Decided

Decided

Hemashield Microvel/Woven Double Velour Fabric

K931386510(k) TraditionalDecided May 27, 199370-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

Meadox Medicals, Div. Boston Scientific Corp. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on May 27, 1993 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 121 later devices descend from it.

Decided: May 27, 1993
Review: 70 days
Class: Class II
Product code: DXZ
Recalls: None
Predicates: 0

121 later devices descend from it, 1 citing it directly.

This deviceK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
Descendant · cites it directly · 120 of its ownK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
Descendant · 2 generations on · 115 of its ownK972651 IN-SlingInfluence, Inc. · 1997
Descendant · 3 generations on · 114 of its ownK980482 Triangle SlingInfluence, Inc. · 1998
Descendant · 4 generations on · 113 of its ownK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
Descendant · 5 generations on · 80 of its ownK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

1996high 14 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 121 · See all

K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek…Vascutek, Ltd. · 1996 · cites it directly120descendants
K972651IN-SlingInfluence, Inc. · 1997 · 2 generations on115descendants
K980482Triangle SlingInfluence, Inc. · 1998 · 3 generations on114descendants
K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000 · 4 generations on113descendants
K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001 · 5 generations on80descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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
+2	K972651	IN-Sling	Influence, Inc.	1997	—
+3	K980482	Triangle Sling	Influence, Inc.	1998	—
+4	K002721	Ams Triangle Silicone-Coated Sling and Surgical Mesh	American Medical Systems, Inc.	2000	—
+5	K010931	Ams Sacral Colpopexy Sling, Model 72403501	American Medical Systems, Inc.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	2	0
2000	1	0
2001	1	0
2003	1	0
2004	4	0
2005	2	0
2006	5	0
2007	1	0
2008	13	0
2009	9	0
2010	5	0
2011	9	0
2012	14	0
2013	9	0
2014	5	0
2015	5	0
2016	3	0
2017	2	0
2018	6	0
2019	1	0
2020	4	0
2021	1	0
2022	3	0
2023	3	0
2024	3	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K931386, 1993–2026Source: 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.

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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (121)

See all 121

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K963611	Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek…	Vascutek, Ltd.	1996	120

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?

Of its descendants, K963611 (Vascutek, Ltd., 1996) has gone furthest, with 120 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/K931386 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931386: Hemashield Microvel/Woven Double Velour Fabric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931386

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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