510(k) · Cleared

Cleared

XenoSure Dura Biologic Patch

K183513510(k) TraditionalCleared Jun 13, 2019177-day reviewClass II21 CFR 882.5910

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

LeMaitre Vascular, Inc. · GXQ Dura Substitute

Cleared on Jun 13, 2019 as substantially equivalent to K973706 (Bio-Vascular, Inc., 1997) after a 177-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jun 13, 2019
Review: 177 days
Class: Class II
Product code: GXQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K950956 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
1 generation backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
This deviceK183513 XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950956	Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute	Bio-Vascular, Inc.	1995	—
−1	K973706	Dura-Guard-Dural Repair Patch	Bio-Vascular, Inc.	1997	—
0 (this device)	K183513	XenoSure Dura Biologic Patch	LeMaitre Vascular, Inc.	2019	—

FIG. 1 — Lineage of K183513, 1995–2019Source: 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.

Planning a device in GXQ? 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 GXQ device

#1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 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
*	K973706	Dura-Guard-Dural Repair Patch Summary page 4 …n: 1220948 Establishment: 63 Second Avenue Burlington, MA 01803 Predicate Device: Dura-Guard Dura Repair Patch K973706 Reference Device: XenoSure Biologic Patch K040835…	Bio-Vascular, Inc.	1997	—
†	K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	—

Also cleared against K973706: 3 other devices →

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 24 years and passes through 2 companies; a new generation was cleared every 21.5 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K973706.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · GXQ

2in 2025

2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXQ

94in 2016

2007high 214 (2015) · low 94 (2016)2026

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

Recalls per year · GXQ

2in 2024

2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXQ

61in 2025

2007high 114 (2020) · low 18 (2014)2025

MAUDE reports naming product code GXQ, 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	2	—	0	55
2008	0	—	0	43
2009	0	—	0	46
2010	1	—	6	36
2011	0	—	0	31
2012	2	—	0	38
2013	3	181	1	72
2014	1	—	0	18
2015	3	214	0	62
2016	3	94	0	58
2017	2	—	0	57
2018	0	—	0	94
2019	1	—	0	63
2020	0	—	0	114
2021	0	—	2	76
2022	1	—	0	59
2023	1	—	0	109
2024	0	—	2	55
2025	2	—	0	61
2026	0	—	0	—

What is it indicated for?

The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183513 · printed Nov 5, 2026

Cite this page

510(k) Report. “K183513: XenoSure Dura Biologic Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183513

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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