510(k) · Cleared
Recalled · Class I · 2015VASCU-GUARD Peripheral Vascular Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Life Technologies, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Nov 25, 2014 as substantially equivalent to K983602 (Bio-Vascular, Inc., 1998) after an 84-day review. Its family tree reaches back 3 generations to 1992. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 25, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921895 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK983602 CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998 · Recalled
- This deviceK142461 VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK221032 Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K983602 | CV Peri-Guard and Vascu-Guard | Bio-Vascular, Inc. | 1998 | 3 |
| 0 (this device) | K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014 | — |
| +1 | K221032 | Vascu-Guard Vascular Repair Patch | Synovis Life Technologies, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K983602 | CV Peri-Guard and Vascu-GuardSummary page 4…acardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ Predicate Devices: Synovis Life Technologies, VASCU-GUARD Peripheral Vascular Patch: K983602 Device Description: VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde.… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair Patch | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2015 | Class I | Z-1637-2015 | Under Investigation by firm | Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K221032 (Synovis Life Technologies, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K983602.
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. 2014, 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?
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142461: VASCU-GUARD Peripheral Vascular Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142461
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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