510(k) · Cleared
ClearedPericardial Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Edwards Laboratories · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Nov 1, 1984 after a 372-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 1, 1984
- Review
- 372 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK833763 Pericardial PatchAmerican Edwards Laboratories · 1984
- Descendant · cites it directly · 5 of its ownK082139 Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008
- Descendant · 2 generations on · 3 of its ownK130872 CardiocelCelxcel Pty, Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK162579 VascuCelAdmedus Regen Pty, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK200566 ADAPT TissueAdmedus Regen Pty, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK172660 Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008 · cites it directly5descendants
- K130872CardiocelCelxcel Pty, Ltd. · 2014 · 2 generations on3descendants
- K162579VascuCelAdmedus Regen Pty, Ltd. · 2016 · 3 generations on1descendant
- K200566ADAPT TissueAdmedus Regen Pty, Ltd. · 2020 · 3 generations on0descendants
- K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K833763 | Pericardial Patch | American Edwards Laboratories | 1984 | — |
| +1 | K082139 | Edwards Bovine Pericardial Patch, Model 4700 | Edwards Lifesciences, LLC | 2008 | — |
| +2 | K130872 | Cardiocel | Celxcel Pty, Ltd. | 2014 | — |
| +3 | K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016 | — |
| +3 | K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | 2020 | — |
| +2 | K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082139 | Edwards Bovine Pericardial Patch, Model 4700 | 2008 | 5 |
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, K082139 (Edwards Lifesciences, LLC, 2008) has gone furthest, with 5 descendants 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/K833763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K833763: Pericardial Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833763
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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