510(k) · Cleared

Cleared

Preclude Dura Substitute

K953969510(k) TraditionalCleared Nov 1, 199571-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

W. L. Gore & Associates, Inc. · GXQ Dura Substitute

Cleared on Nov 1, 1995 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided: Nov 1, 1995
Review: 71 days
Class: Class II
Product code: GXQ
Recalls: None
Predicates: 0

31 later devices descend from it, 2 citing it directly.

This deviceK953969 Preclude Dura SubstituteW. L. Gore & Associates, Inc. · 1995
Descendant · cites it directly · 30 of its ownK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
Descendant · 2 generations on · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled
Descendant · 2 generations on · 7 of its ownK041000 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004
Descendant · 3 generations on · 5 of its ownK052211 Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005
Descendant · 3 generations on · 3 of its ownK063117 Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1999high 4 (2004) · low 0 (2000)2026

Most influential descendants

Showing 5 of 31 · See all

K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · cites it directly30descendants
K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · 2 generations on9descendants
K041000Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2004 · 2 generations on7descendants
K052211Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2005 · 3 generations on5descendants
K063117Modification to Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 2006 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953969	Preclude Dura Substitute	W. L. Gore & Associates, Inc.	1995	—
+1	K982180	Duragen Dural Graft Matrix	Integra Lifesciences Corp.	1999	1
+2	K032693	Duragen Plus Dural Graft Matrix	Integra Lifesciences Corp.	2003	1
+2	K041000	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	2004	—
+3	K052211	Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	2005	—
+3	K063117	Modification to Durepair Dura Regeneration Matrix	Medtronic Neurosurgery	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	2	0
2004	4	0
2005	2	0
2006	2	0
2007	2	0
2010	1	0
2012	2	0
2013	3	0
2014	1	0
2015	3	0
2016	2	0
2017	2	0
2022	1	0
2025	2	0

FIG. 1 — Lineage of K953969, 1995–2025Source: 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 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

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? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K982180	Duragen Dural Graft Matrix	Integra Lifesciences Corp.	1999	30
K021477	Preclude MVP Dura Substitute	W. L. Gore & Associates, Inc.	2002	3

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, K982180 (Integra Lifesciences Corp., 1999) has gone furthest, with 30 descendants of its own.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K953969 · printed Nov 5, 2026

Cite this page

510(k) Report. “K953969: Preclude Dura Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953969

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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