510(k) · Cleared

Cleared

Shelhigh NO-React Pericardial Patches

K974914510(k) TraditionalCleared Jun 3, 1998177-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

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

Cleared on Jun 3, 1998 as substantially equivalent to K964467 (Shelhigh, Inc., 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997. 15 later devices descend from it.

Decided: Jun 3, 1998
Review: 177 days
Class: Class II
Product code: DXZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K964467 (1997). 15 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK964467 Shelhigh Pericardial PatchShelhigh, Inc. · 1997
This deviceK974914 Shelhigh NO-React Pericardial PatchesShelhigh, Inc. · 1998
Descendant · cites it directly · 12 of its ownK982810 Shelhigh NO-React VascupatchShelhigh, Inc. · 1998
Descendant · 2 generations on · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
Descendant · 3 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
Descendant · 4 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
Descendant · 5 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1998high 2 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 15 · See all

K982810Shelhigh NO-React VascupatchShelhigh, Inc. · 1998 · cites it directly12descendants
K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · 2 generations on11descendants
K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 3 generations on4descendants
K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 4 generations on3descendants
K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964467	Shelhigh Pericardial Patch	Shelhigh, Inc.	1997	—
0 (this device)	K974914	Shelhigh NO-React Pericardial Patches	Shelhigh, Inc.	1998	—
+1	K982810	Shelhigh NO-React Vascupatch	Shelhigh, Inc.	1998	—
+2	K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	—
+3	K140306	Cormatrix Protect Ecm Envelope	Cormatrix Cardiovascular, Inc.	2014	2
+4	K173242	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…	Aziyo Biologics, Inc.	2017	1
+5	K182255	CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo…	Aziyo Biologics, Inc.	2018	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2007	1	0
2008	1	0
2011	1	0
2014	2	0
2016	1	0
2017	1	0
2018	2	0
2019	1	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K974914, 1997–2021Source: 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? (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
*	K964467	Shelhigh Pericardial Patch Summary page 2 …ong history of success as a permanently implanted material. V. Substantial Equivalence It is substantially equivalent to the Shelhigh pericardial patch #K964467 manufactured by Shelhigh Inc.. VI. Comparison with Predicate Device The Shelhigh No-React® Pericardial patch like the Shelhigh…	Shelhigh, Inc.	1997	—

Also cleared against K964467: 1 other device →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K982810	Shelhigh NO-React Vascupatch	Shelhigh, Inc.	1998	12
K981756	Shelhigh NO-React Pneumopledgets	Shelhigh, Inc.	1998	1
K991567	Shelhigh NO-React Tissue Repair Patch/Uropatch.	Shelhigh, Inc.	1999	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?

Its one ancestor has no recall.
Of its descendants, K982810 (Shelhigh, Inc., 1998) has gone furthest, with 12 descendants of its own.
1 other device also cites its predicate K964467.

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 Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974914 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974914: Shelhigh NO-React Pericardial Patches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974914

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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