510(k) · Cleared

Cleared

Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM

K132850510(k) TraditionalCleared Mar 31, 2014201-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

Rti Surgical, Inc. · GXQ Dura Substitute

Cleared on Mar 31, 2014 as substantially equivalent to K950956 (Bio-Vascular, Inc., 1995) and 3 other predicates after a 201-day review. Its family tree reaches back 5 generations to 1995.

Decided: Mar 31, 2014
Review: 201 days
Class: Class II
Product code: GXQ
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K950956 (1995). 9 ancestors in all, the oldest K910555 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
4 generations backK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
3 generations backK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
2 generations backK040888 Duramatrix Collagen Dura Substitute MembraneCollagen Matrix, Inc. · 2004
1 generation backK061487 Duramatrix Collagen Dura Substitute Membrane - Onlay and SuturableCollagen Matrix, Inc. · 2006 · Recalled
This deviceK132850 Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft…Rti Surgical, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K950956	Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute	Bio-Vascular, Inc.	1995	—
−4	K973706	Dura-Guard-Dural Repair Patch	Bio-Vascular, Inc.	1997	—
−3	K982180	Duragen Dural Graft Matrix	Integra Lifesciences Corp.	1999	1
−2	K040888	Duramatrix Collagen Dura Substitute Membrane	Collagen Matrix, Inc.	2004	—
−1	K061487	Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable	Collagen Matrix, Inc.	2006	2
0 (this device)	K132850	Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine…	Rti Surgical, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	1	0
1997	1	0
1998	1	0

FIG. 1 — Lineage of K132850, 1995–2014Source: 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K950956	Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute Summary page 1 …d Code: Dura substitute (21 CFR 882.5910, product code GXQ) Substantial Equivalence: The proposed device is substantially equivalent to the predicate device Dura-Guard (K950956 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device issubstantially equivalen…	Bio-Vascular, Inc.	1995	—
*	K982282	Dura-Guard - Dural Repair Patch Summary page 1 …substitute (21 CFR 882.5910, product code GXQ) Substantial Equivalence: The proposed device is substantially equivalent to the predicate device Dura-Guard (K950956 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device issubstantially equivalent to the pre…	Bio-Vascular, Inc.	1998	1
*	K970851	Lyoplant Dura Substitute (Various) Summary page 1 ….5910, product code GXQ) Substantial Equivalence: The proposed device is substantially equivalent to the predicate device Dura-Guard (K950956 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device issubstantially equivalent to the predicate device Dura-Matr…	Aesculap, Inc.	1997	—
*	K061487	Duramatrix Collagen Dura Substitute Membrane - Onlay and Suturable Summary page 1 …6 and K982282) and Lyoplant (K970851) in intended use, material, design and function. The proposed device issubstantially equivalent to the predicate device Dura-Matrix (K061487) in intended use, design and function. The proposed device is similar in design, function, materials and processing to reference…	Collagen Matrix, Inc.	2006	2
†	K991296	Tutopatch	Tutogen Medical U.S., Inc.	2000	—
†	K073097	Tutodent Dental Membrane	Tutogen Medical U.S., Inc.	2008	—
†	K081538	Tutopatch, Tutomesh	Rti Biologics, Inc.	2008	—
†	K091142	Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358	Rti Biologics, Inc.	2009	—
†	K910555	Tutoplast Dura	Pfrimmer-Viggo GmbH & Co.	1992	—

Also cleared against K950956: 5 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 19 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
3 of the 9 ancestors have a recall of any class.
5 other devices also cite its predicate K950956.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 device is indicated as a dura substitute for the repair of dura mater.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132850 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132850: Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132850

Report an extraction error

Are you the manufacturer?

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