510(k) Report

510(k) · Cleared

Cleared

Peri-Guard Pericardial Patch

K842066510(k) TraditionalCleared Dec 30, 1985616-day reviewClass II21 CFR 870.3470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genetic Laboratories, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Dec 30, 1985 after a 616-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 341 devices in its family, counting itself, has a Class I recall. 340 later devices descend from it.

Decided
Dec 30, 1985
Review
616 days
Class
Class II
Product code
DXZ
Recalls
None
Predicates
0

340 later devices descend from it, 4 citing it directly. 1 of the 341 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 2 descendants cleared2013: 17 descendants cleared1997: 1 descendant cleared1996: 1 descendant cleared2000: 3 descendants cleared2004: 10 descendants cleared2003: 6 descendants cleared2023: 13 descendants cleared2015: 12 descendants cleared2002: 6 descendants cleared2006: 8 descendants cleared2008: 17 descendants cleared2005: 7 descendants cleared2014: 20 descendants cleared2009: 12 descendants cleared2007: 13 descendants cleared2010: 13 descendants cleared2020: 10 descendants cleared2019: 12 descendants cleared2017: 28 descendants cleared2012: 15 descendants cleared2022: 15 descendants cleared2018: 17 descendants cleared2016: 20 descendants cleared2011: 12 descendants cleared, 1 with a Class I recall12026: 15 descendants cleared2025: 11 descendants cleared2021: 12 descendants cleared2024: 12 descendants cleared1990200020102020
  1. This deviceK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
  2. Descendant · cites it directly · 339 of its ownK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. Descendant · cites it directly · 336 of its ownK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
  4. Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  5. Descendant · 2 generations on · 147 of its ownK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
  6. Descendant · 3 generations on · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002

Showing 5 of 340 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 22000: 32002: 62003: 62004: 102005: 72006: 82007: 132008: 172009: 122010: 132011: 122012: 152013: 172014: 202015: 122016: 202017: 282018: 172019: 122020: 102021: 122022: 152023: 132024: 122025: 112026: 15
1996high 28 (2017) · low 0 (1999)2026

Class I recalls in this family

  • K111064 Tigerpaw System II4 generations on · 2011

Most influential descendants

Showing 5 of 340 · See all
  • K961811Peri-Guard PericardiumBio-Vascular, Inc. · 1996 · cites it directly339descendants
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc. · 1998 · cites it directly336descendants
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc. · 2000 · 2 generations on147descendants
  • K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · 3 generations on145descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K842066Peri-Guard Pericardial PatchGenetic Laboratories, Inc.1985—
+1K961811Peri-Guard PericardiumBio-Vascular, Inc.1996—
+1K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19982
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+2K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated…Bio-Vascular, Inc.2000—
+3K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199820
200030
200260
200360
2004100
200570
200680
2007130
2008170
2009120
2010130
2011121
2012150
2013170
2014200
2015120
2016200
2017280
2018170
2019120
2020100
2021120
2022150
2023130
2024120
2025110
2026150
FIG. 1 — Lineage of K842066, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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? (340)

See all 340

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961811Peri-Guard PericardiumBio-Vascular, Inc.1996339
K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.1998336
K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc.19971
K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130

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.

  • K111064Tigerpaw System IILaax, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K961811 (Bio-Vascular, Inc., 1996) has gone furthest, with 339 descendants of its own.

How does its category compare?

All DXZ devices

DXZ 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

2007: 12008: 22009: 12010: 32011: 22012: 12013: 12014: 32015: 22016: 22017: 12020: 12025: 1
2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2010: 91 days median2014: 106 days median
2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2010: 22011: 22013: 22018: 12020: 12023: 22025: 2, 2 Class I2026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007: 502008: 62009: 1092010: 812011: 472012: 212013: 692014: 932015: 1712016: 662017: 302018: 442019: 552020: 1212021: 802022: 772023: 402024: 492025: 119
2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—050
20082—06
20091—0109
2010391281
20112—247
20121—021
20131—269
20143106093
20152—0171
20162—066
20171—030
20180—144
20190—055
20201—1121
20210—080
20220—077
20230—240
20240—049
20251—2 (2)119
20260—1—

More from Genetic Laboratories, Inc.

4 FDA decisions under this applicant name. See the company

  • K842621Suture StripGenetic Laboratories, Inc. · 1984
  • K821532Periguard Pericardial PatchGenetic Laboratories, Inc. · 1982
  • P800064Bioflow (TM)Genetic Laboratories, Inc. · 1982

Recent decisions in DXZ

The DXZ category page

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025
  • K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd. · 2020
  • K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc. · 2017
  • K162579VascuCelAdmedus Regen Pty, Ltd. · 2016
  • K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

https://510kreport.com/device/K842066 · printed Nov 6, 2026

Cite this page

510(k) Report. “K842066: Peri-Guard 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/K842066

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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