510(k) · Cleared
Recalled · Class II · 2023Vascu-Guard Vascular 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 K142461 (Synovis Life Technologies, Inc., 2014) and 1 other predicate after a 195-day review. Its family tree reaches back 4 generations to 1992. 1 of the 8 devices in its family, counting itself, has a Class I recall. 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 K921895 (1992). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK983602 CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998 · Recalled
- 1 generation backK142461 VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. · 2014 · Recalled (Class I)
- This deviceK221032 Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc. · 2022
Class I recalls in this family
- K142461 VASCU-GUARD Peripheral Vascular Patchdirect predicate · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K983602 | CV Peri-Guard and Vascu-Guard | Bio-Vascular, Inc. | 1998 | 3 |
| −1 | K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014 | Class I |
| 0 (this device) | K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K142461 | VASCU-GUARD Peripheral Vascular PatchSummary page 4…racardiac Patch Or Pledget, Biologically Derived Product Code: PSQ III. PREDICATE DEVICES Primary: VASCU-GUARD Peripheral Vascular Patch, K142461 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Secondary: VASCU-GUARD Peripheral Vasc… | 2014 |
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 4…eral Vascular Patch, K142461 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Secondary: VASCU-GUARD Peripheral Vascular Patch, K983602 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.) Additionally, Synovis PERI-STRIPS DRY… | 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0666-2024 | 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… |
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.
- K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
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?
VASCU‑GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221032: Vascu-Guard Vascular 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/K221032
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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