510(k) · Cleared
ClearedPeriguard Pericardial Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genetic Laboratories, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Aug 19, 1982 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 19, 1982
- Review
- 87 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK821532 Periguard Pericardial PatchGenetic Laboratories, Inc. · 1982
- Descendant · cites it directly · 1 of its ownK973552 Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK122306 Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013
- Descendant · 2 generations on · 0 of its ownK983581 Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc. · 1997 · cites it directly1descendant
- K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations · 2013 · cites it directly0descendants
- K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821532 | Periguard Pericardial Patch | Genetic Laboratories, Inc. | 1982 | — |
| +1 | K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap | Bio-Vascular, Inc. | 1997 | — |
| +1 | K122306 | Synovis Collagen Matrix (TBD) | Synovis Surgical Innovations | 2013 | — |
| +2 | K983581 | Ocu-Guard and Ocu-Guard Supple | Bio-Vascular, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K973552 (Bio-Vascular, Inc., 1997) has gone furthest, with 1 descendant of its own.
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.
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 | — |
https://510kreport.com/device/K821532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821532: Periguard Pericardial Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821532
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026