510(k) · Cleared
Recalled · Class II · 2023PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Life Technologies, Inc. · PSQ Intracardiac Patch Or Pledget, Biologically Derived
Cleared on Oct 19, 2022 as substantially equivalent to K142447 (Synovis Life Technologies, Inc., 2015) and 1 other predicate after a 195-day review. Its family tree reaches back 4 generations to 1985. It has been recalled once.
- Decided
- Oct 19, 2022
- Review
- 195 days
- Class
- Class II
- Product code
- PSQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K842066 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 1 generation backK142447 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc. · 2015
- This deviceK221029 PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −3 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −1 | K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015 | — |
| 0 (this device) | K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 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 K210331 CardiaMend Pericardial and Epicardial…score 4.7 · 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? (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 |
|---|---|---|---|
| * | K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSummary page 4…Biologically Derived Product Code: PSQ III. PREDICATE DEVICES Primary: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Pericardium Patch, K142447 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Secondary: PERI-G… | 2015 |
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 4…Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Secondary: PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch, K983602 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Additionally, Syn… | 1998 |
| † | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0664-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 2 of the 10 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. 2022, 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?
PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.
SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.
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/K221029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221029: PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221029
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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