510(k) · Cleared

Recalled · Class II · 2024

Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc

K983162510(k) SpecialCleared Oct 9, 199829-day reviewClass II21 CFR 878.3300Recalls 2

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

Cleared on Oct 9, 1998 as substantially equivalent to K961811 (Bio-Vascular, Inc., 1996) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1985. 1 of the 342 devices in its family, counting itself, has a Class I recall. 336 later devices descend from it. It has been recalled 2 times.

Decided: Oct 9, 1998
Review: 29 days
Class: Class II
Product code: FTM
Recalls: 2
Predicates: 4

Its longest line of descent runs back 2 generations to K842066 (1985). 5 ancestors in all. 336 later devices descend from it, 13 citing it directly. 1 of the 342 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
1 generation backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
This deviceK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998
Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
Descendant · cites it directly · 147 of its ownK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
Descendant · 2 generations on · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
Descendant · 3 generations on · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
Descendant · 4 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003

Showing 5 of 336 descendants. See all descendants

Descendants cleared per year

2000high 28 (2017) · low 0 (2001)2026

Class I recalls in this family

K111064 Tigerpaw System II3 generations on · 2011

Most influential descendants

Showing 5 of 336 · See all

K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc. · 2000 · cites it directly147descendants
K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · 2 generations on145descendants
K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 3 generations on143descendants
K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 4 generations on102descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K842066	Peri-Guard Pericardial Patch	Genetic Laboratories, Inc.	1985	—
−1	K961811	Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
0 (this device)	K983162	Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…	Bio-Vascular, Inc.	1998	—
+1	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
+1	K992537	Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated…	Bio-Vascular, Inc.	2000	—
+2	K014183	Afb (Absorbable Foam Buttress)	J&J Corporate Biomaterials Center	2002	—
+3	K030782	Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2003	—
+4	K032865	Gore Seamguard Bioabsorbable Staple Line Reinforcement Material	W. L. Gore & Associates, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	3	0
2002	6	0
2003	6	0
2004	10	0
2005	7	0
2006	8	0
2007	13	0
2008	17	0
2009	12	0
2010	13	0
2011	12	1
2012	15	0
2013	17	0
2014	20	0
2015	12	0
2016	20	0
2017	28	0
2018	17	0
2019	12	0
2020	10	0
2021	12	0
2022	15	0
2023	13	0
2024	12	0
2025	11	0
2026	15	0

FIG. 1 — Lineage of K983162, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FTM device

#1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K961811	Peri-Guard Pericardium Summary page 1 …de Name: Peri-Guard Repair Patch Common Name: ’ Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FT™M , O)Iﬁ Predicate devices: Peri-Guard K961811 and K842066 {Device acting as its own predicate) Device Description: Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue…	Bio-Vascular, Inc.	1996	—
*	K842066	Peri-Guard Pericardial Patch Summary page 1 …i-Guard Repair Patch Common Name: ’ Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FT™M , O)Iﬁ Predicate devices: Peri-Guard K961811 and K842066 {Device acting as its own predicate) Device Description: Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared fr…	Genetic Laboratories, Inc.	1985	—
*	K961810	Supple Peri-Guard Pericardium Summary page 3 …e: Supple Peri-Guard Pericardium Common Name: Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FT™M Predicate devices: ) Supple Peri-Guard K961810 and K921895 (Device acting as its own predicate) Device Description: Supple Peri-Guard® is prepared from bovine pericardium whi…	Bio-Vascular, Inc.	1996	—
*	K921895	Tissue Patch, Tissue Graft Summary page 3 …ri-Guard Pericardium Common Name: Surgical Mesh Classification Name: Mesh, Surgical 21 CFR 878.3300 Product Code: FT™M Predicate devices: ) Supple Peri-Guard K961810 and K921895 (Device acting as its own predicate) Device Description: Supple Peri-Guard® is prepared from bovine pericardium which is cross-…	Bio-Vascular, Inc.	1992	—

Also cleared against K961811: 2 other devices →

What descends from it? (336)

See all 336

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

Number	Device	Applicant	Decided	Descendants
K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	173
K992537	Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…	Bio-Vascular, Inc.	2000	147
K043366	Permacol Surgical Implant	Tissue Science Laboratories, Plc	2004	74
K040119	Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…	Synovis Surgical Innovations	2004	69
K040415	Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…	Synovis Surgical Innovations	2004	24
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16	Pm Devices, Inc.	2004	17
K023237	Xylos Surgical Mesh	Xylos Corporation	2003	12
K022044	Surgisis Staple Line Reinforcement	Cook Biotech, Inc.	2002	6
K142447	PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch	Synovis Life Technologies, Inc.	2015	1
K033985	Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10	Pm Devices, Inc.	2004	1

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 28, 2024	Class II	Z-1378-2024	Labeling Change Control	A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices…
Feb 28, 2024	Class II	Z-1377-2024	Labeling Change Control	A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices…

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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K001738 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 173 descendants of its own.
2 other devices also cite its predicate K961811.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTM

1in 2025

2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007high 316 (2015) · low 29 (2024)2026

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

Recalls per year · FTM

1in 2023

2007high 21 (2018) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTM

232in 2025

2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, 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	9	104	7	60
2008	9	86	1	141
2009	7	86	0	476
2010	2	—	1	197
2011	6	100	8	288
2012	4	66	0	467
2013	4	123	0	3,351
2014	8	153	0	1,093
2015	4	316	0	977
2016	7	88	0	509
2017	9	147	0	529
2018	2	—	21	357
2019	6	107	4	418
2020	4	59	1	457
2021	4	61	1	369
2022	0	—	0	375
2023	2	—	1	485
2024	3	29	0	383
2025	1	—	0	232
2026	1	—	0	—

What is it indicated for?

Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K983162 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983162

Report an extraction error

Are you the manufacturer?

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