510(k) · Cleared

Cleared

Regensis Pericardial Patch

K051405510(k) TraditionalCleared Aug 31, 200592-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

Cormatrix Cardiovascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Aug 31, 2005 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 3 other predicates after a 92-day review. Its family tree reaches back 4 generations to 1992. 15 later devices descend from it.

Decided: Aug 31, 2005
Review: 92 days
Class: Class II
Product code: DXZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K921895 (1992). 10 ancestors in all, the oldest K830889 (1983). 15 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
1 generation backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
This deviceK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
Descendant · cites it directly · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
Descendant · 2 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
Descendant · 3 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
Descendant · 4 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
Descendant · 2 generations on · 2 of its ownK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all

K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · cites it directly11descendants
K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 2 generations on4descendants
K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 3 generations on3descendants
K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 4 generations on2descendants
K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K921895	Tissue Patch, Tissue Graft	Bio-Vascular, Inc.	1992	—
−3	K961810	Supple Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−2	K980431	Surgisis	Cook Biotech, Inc.	1998	—
−1	K020455	Tissuemend Soft Tissue Repair Matrix	Tei Biosciences, Inc.	2002	—
0 (this device)	K051405	Regensis Pericardial Patch	Cormatrix Cardiovascular, Inc.	2005	—
+1	K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	—
+2	K140306	Cormatrix Protect Ecm Envelope	Cormatrix Cardiovascular, Inc.	2014	2
+3	K173242	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…	Aziyo Biologics, Inc.	2017	1
+4	K182255	CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo…	Aziyo Biologics, Inc.	2018	1
+2	K152127	CorMatrix Tyke	Cormatrix Cardiovascular, Inc.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1992	1	0
1997	1	0
2000	1	0
2001	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2013	1	0
2014	2	0
2016	1	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K051405, 1992–2021Source: 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 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? (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
*	K980431	Surgisis Summary page 1 …duct Code: Product Code: DXZ Device Classification Name: Patch, Pericardial Device Classification: Class II PREDICATE DEVICES * Cook Biotech, Inc., SurgiSIS (K98043 1) * TEI Biosciences, Inc., TISSUEMEND (K020455) * W.L. Gore &Associates,lInc., Preclude Pericardial Membrane (K012098)…	Cook Biotech, Inc.	1998	—
*	K020455	Tissuemend Soft Tissue Repair Matrix Summary page 1 …Name: Patch, Pericardial Device Classification: Class II PREDICATE DEVICES * Cook Biotech, Inc., SurgiSIS (K98043 1) * TEI Biosciences, Inc., TISSUEMEND (K020455) * W.L. Gore &Associates,lInc., Preclude Pericardial Membrane (K012098) * PM Devices, Inc., Peripatch Sheet (K03 1948)…	Tei Biosciences, Inc.	2002	—
*	K012098	Preclude Pericardial Membrane Summary page 1 …ICES * Cook Biotech, Inc., SurgiSIS (K98043 1) * TEI Biosciences, Inc., TISSUEMEND (K020455) * W.L. Gore &Associates,lInc., Preclude Pericardial Membrane (K012098) * PM Devices, Inc., Peripatch Sheet (K03 1948) INTENDED USE The CorMatrix Pericardial Patch is intended for…	W. L. Gore & Associates, Inc.	2001	—
*	K031948	Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 Summary page 1 …* TEI Biosciences, Inc., TISSUEMEND (K020455) * W.L. Gore &Associates,lInc., Preclude Pericardial Membrane (K012098) * PM Devices, Inc., Peripatch Sheet (K03 1948) INTENDED USE The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.…	Pm Devices, Inc.	2003	—

Also cleared against K980431: 28 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	11
K210331	CardiaMend Pericardial and Epicardial Reconstruction Matrix	Helios Cardio, Inc.	2021	0
K191734	MatriStem UBM Pericardial Patch	Acell, Inc.	2019	0
K122306	Synovis Collagen Matrix (TBD)	Synovis Surgical Innovations	2013	0
K090637	Cardio-Wrap	Mast Biosurgery USA, Inc.	2010	0

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 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
None of the 10 ancestors has a recall.
Of its descendants, K063349 (Cormatrix Cardiovascular, Inc., 2007) has gone furthest, with 11 descendants of its own.
28 other devices also cite its predicate K980431.

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	—

What is it indicated for?

The CorMatrix Pericardial Patch is intended for the reconstruction and repair of the pericardium.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051405: Regensis Pericardial Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051405

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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