510(k) · Cleared
ClearedCardiaMend Pericardial and Epicardial Reconstruction Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helios Cardio, Inc. · PSQ Intracardiac Patch Or Pledget, Biologically Derived
Cleared on Dec 21, 2021 as substantially equivalent to K181038 (Cormatrix Cardiovascular, Inc., 2018) and 1 other predicate after a 319-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Dec 21, 2021
- Review
- 319 days
- Class
- Class II
- Product code
- PSQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921895 (1992). 27 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- 4 generations backK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
- 3 generations backK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- 2 generations backK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016
- 1 generation backK181038 CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch…Cormatrix Cardiovascular, Inc. · 2018
- This deviceK210331 CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| −4 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | — |
| −3 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| −2 | K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016 | — |
| −1 | K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7… | Cormatrix Cardiovascular, Inc. | 2018 | — |
| 0 (this device) | K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
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 PSQ? 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 PSQ device
- #1 K221029 PERI-GUARD Repair Patch, SUPPLE PERI-GUARD…score 3.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Summary page 4…ode: PSQ Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: ● CorMatrix ® Cor Patch, K181038, CorMatrix Cardiovascular, Inc. ● CorMatrix Pericardial Patch (currently marketed as ProxiCor for Pericardial Closure by… | 2018 |
| * | K051405 | Regensis Pericardial PatchSummary page 4…Patch, K181038, CorMatrix Cardiovascular, Inc. ● CorMatrix Pericardial Patch (currently marketed as ProxiCor for Pericardial Closure by Aziyo Biologics, Inc.), K051405, CorMatrix Cardiovascular, Inc. The following devices are cited as reference devices within the submission: ● SurgiMend™ Coll… | 2005 |
| † | K071807 | Orthomend Soft Tissue Matrix | 2007 |
| † | K041000 | Durepair Dura Regeneration Matrix | 2004 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 27 ancestors have a recall of any class.
How does its category compare?
All PSQ devicesPSQ Intracardiac Patch Or Pledget, Biologically Derived: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PSQ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PSQ
73in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSQ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSQ
1in 2025
MAUDE reports naming product code PSQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 73 | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 2 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 2 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
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/K210331 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210331: CardiaMend Pericardial and Epicardial Reconstruction Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210331
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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