510(k) · Cleared
ClearedEdwards Bovine Pericardial Patch, Model 4700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Oct 23, 2008 as substantially equivalent to K833763 (American Edwards Laboratories, 1984) and 4 other predicates after an 86-day review. Its family tree reaches back 4 generations to 1985. 1 of the 19 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 23, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K842066 (1985). 13 ancestors in all, the oldest K830863 (1983). 5 later devices descend from it, 2 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- 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 backK040835 Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc. · 2004
- This deviceK082139 Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC · 2008
- Descendant · cites it directly · 3 of its ownK130872 CardiocelCelxcel Pty, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK162579 VascuCelAdmedus Regen Pty, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK200566 ADAPT TissueAdmedus Regen Pty, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK172660 Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK170951 CardioCel 3DAdmedus Regen Pty, Ltd. · 2017
Class I recalls in this family
- K963967 Glycar Pericardial Patchdirect predicate · 1997
Most influential descendants
Showing 5 of 5 · See all- K130872CardiocelCelxcel Pty, Ltd. · 2014 · cites it directly3descendants
- K162579VascuCelAdmedus Regen Pty, Ltd. · 2016 · 2 generations on1descendant
- K200566ADAPT TissueAdmedus Regen Pty, Ltd. · 2020 · 2 generations on0descendants
- K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC · 2017 · cites it directly0descendants
- K170951CardioCel 3DAdmedus Regen Pty, Ltd. · 2017 · 2 generations on0descendants
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 | K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 | Pm Devices, Inc. | 2004 | — |
| 0 (this device) | K082139 | Edwards Bovine Pericardial Patch, Model 4700 | Edwards Lifesciences, LLC | 2008 | — |
| +1 | K130872 | Cardiocel | Celxcel Pty, Ltd. | 2014 | — |
| +2 | K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016 | — |
| +2 | K200566 | ADAPT Tissue | Admedus Regen Pty, Ltd. | 2020 | — |
| +1 | K172660 | Duravess bovine pericardial vascular patch | Edwards Lifesciences, LLC | 2017 | — |
| +2 | K170951 | CardioCel 3D | Admedus Regen Pty, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 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? (5)
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 |
|---|---|---|---|
| * | K833763 | Pericardial PatchSummary page 1…e Pericardial Patch Classification Intracardiac Patch or Pledget (21 CFR 870.3470, Product Code DXZ) Name: Predicate Devices: Edwards Bovine Pericardial Patch, K833763 PeriPatCh TM Sheet, K040835 CV Peni-Guard Cardiovascular Patch, K971726… | 1984 |
| * | K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Summary page 1…diac Patch or Pledget (21 CFR 870.3470, Product Code DXZ) Name: Predicate Devices: Edwards Bovine Pericardial Patch, K833763 PeriPatCh TM Sheet, K040835 CV Peni-Guard Cardiovascular Patch, K971726 Glycar Pericardial Patch, K963967… | 2004 |
| * | K971726 | CV Peri-Guard - Cardiovascular PatchSummary page 1…Predicate Devices: Edwards Bovine Pericardial Patch, K833763 PeriPatCh TM Sheet, K040835 CV Peni-Guard Cardiovascular Patch, K971726 Glycar Pericardial Patch, K963967 Vascu-Guard, K942010 Device The… | 1998 |
| * | K963967 | Glycar Pericardial PatchSummary page 1…K833763 PeriPatCh TM Sheet, K040835 CV Peni-Guard Cardiovascular Patch, K971726 Glycar Pericardial Patch, K963967 Vascu-Guard, K942010 Device The Edwards Bovine Pericardial Patch is comprised of a rect… | 1997 |
| * | K942010 | Vascu-GuardSummary page 1…Sheet, K040835 CV Peni-Guard Cardiovascular Patch, K971726 Glycar Pericardial Patch, K963967 Vascu-Guard, K942010 Device The Edwards Bovine Pericardial Patch is comprised of a rectangular sheet of Description:… | 1994 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K963967Glycar Pericardial PatchGlycar, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130872 (Celxcel Pty, Ltd., 2014) has gone furthest, with 3 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. 2008, 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?
The pericardial patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following open-heart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082139: Edwards Bovine Pericardial Patch, Model 4700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082139
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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