510(k) · Cleared
ClearedCorMatrix Tyke
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cormatrix Cardiovascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Feb 4, 2016 as substantially equivalent to K063349 (Cormatrix Cardiovascular, Inc., 2007) after a 188-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 4, 2016
- Review
- 188 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921895 (1992). 25 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- 2 generations backK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
- 1 generation backK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
- This deviceK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK181038 CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch…Cormatrix Cardiovascular, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK210331 CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| −2 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | — |
| −1 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 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
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 | Decided |
|---|---|---|---|
| * | K063349 | Cormatrix Patch for Cardiac Tissue RepairSummary page 4…Product Code DXZ, Class II Predicate Devices The CorMatrix® Tyke™ is substantially equivalent to CorMatrix® ECM® for Cardiac Tissue Repair, K063349. Device Description CorMatrix® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epi… | 2007 |
| † | K051405 | Regensis Pericardial Patch | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single… | 2018 | 1 |
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 24 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K181038 (Cormatrix Cardiovascular, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K063349.
How does its category compare?
All DXZ devicesDXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 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® Tyke™ is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152127: CorMatrix Tyke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152127
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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