510(k) · Cleared
ClearedCardioCel 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Admedus Regen Pty, Ltd. · PSQ Intracardiac Patch Or Pledget, Biologically Derived
Cleared on Apr 28, 2017 as substantially equivalent to K130872 (Celxcel Pty, Ltd., 2014) after a 28-day review. Its family tree reaches back 6 generations to 1985. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 28, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- PSQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K842066 (1985). 15 ancestors in all, the oldest K830863 (1983). No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 3 generations backK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
- 2 generations backK082139 Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008
- 1 generation backK130872 CardiocelCelxcel Pty, Ltd. · 2014
- This deviceK170951 CardioCel 3DAdmedus Regen Pty, Ltd. · 2017
Class I recalls in this family
- K963967 Glycar Pericardial Patch3 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −5 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −3 | K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 | Pm Devices, Inc. | 2004 | — |
| −2 | K082139 | Edwards Bovine Pericardial Patch, Model 4700 | Edwards Lifesciences, LLC | 2008 | — |
| −1 | K130872 | Cardiocel | Celxcel Pty, Ltd. | 2014 | — |
| 0 (this device) | K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 2003 | 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.
1 device in this family has a Class I recall. 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 K210331 CardiaMend Pericardial and Epicardial…score 4.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K130872 | CardiocelSummary page 4…iac Patch or Pledget, Biologically Derived Classification Class II, 21 CFR § 870.3470 Product Code PSQ Predicate Device CardioCel (K130872) Device Description The CardioCel 3D device is a bovine pericardial patch prepared from gluta… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K130872.
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. 2017, 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?
CardioCel 3D is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170951: CardioCel 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170951
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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