510(k) · Cleared

Cleared

Ventrio Light Hernia Patch with TRM Antimicrobial Coating

K113229510(k) TraditionalCleared Jul 20, 2012261-day reviewClass II21 CFR 878.3300

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

C.R. Bard, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Jul 20, 2012 as substantially equivalent to K081777 (C.R. Bard, Inc., 2008) and 3 other predicates after a 261-day review. Its family tree reaches back 11 generations to 1992. 3 later devices descend from it.

Decided: Jul 20, 2012
Review: 261 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 4

Its longest line of descent runs back 11 generations to K921895 (1992). 80 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
7 generations between
3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
2 generations backK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
1 generation backK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
This deviceK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
Descendant · cites it directly · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
Descendant · 2 generations on · 0 of its ownK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016

Show all 11 generations

Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
4 generations backK052830 SportmeshArtimplant AB · 2006
3 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
2 generations backK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
1 generation backK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
This deviceK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012

Most influential descendants

Showing 3 of 3 · See all

K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · cites it directly2descendants
K151177XenMatrix AB Surgical GraftC. R. Bard · 2015 · 2 generations on1descendant
K162193XenMatrix AB Surgical GraftC. R. Bard · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K921895	Tissue Patch, Tissue Graft	Bio-Vascular, Inc.	1992	—
−10	K961810	Supple Peri-Guard Pericardium	Bio-Vascular, Inc.	1996	—
−9	K980431	Surgisis	Cook Biotech, Inc.	1998	—
−8	K992159	Surgisis Sling	Cook Biotech, Inc.	1999	—
−7	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
−6	K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	2002	—
−5	K042809	Cuffpatch	Organogenesis, Inc.	2004	—
−4	K052830	Sportmesh	Artimplant AB	2006	—
−3	K071887	Sportmesh or Artelon Tissue Reinforcement	Artimplant AB	2007	—
−2	K090271	Hydrocoat Mesh	Promethean Surgical Devices, Inc.	2010	—
−1	K093524	Pivit a/B ST and Pivit a/B ST-R	Tyrx, Inc.	2010	—
0 (this device)	K113229	Ventrio Light Hernia Patch with TRM Antimicrobial Coating	C.R. Bard, Inc.	2012	—
+1	K133223	Xenmatrix AB Surgical Graft	C.R. Bard, Inc.	2014	—
+2	K151177	XenMatrix AB Surgical Graft	C. R. Bard	2015	—
+2	K162193	XenMatrix AB Surgical Graft	C. R. Bard	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0
1988	1	0
1990	1	0
1991	3	0
1992	2	0
1993	2	0
1994	1	0
1996	5	0
1997	4	0
1998	8	0
1999	1	0
2000	11	0
2001	3	0
2002	5	0
2003	1	0
2004	7	0
2005	3	0
2006	4	0
2007	2	0
2008	2	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2016	1	0

FIG. 1 — Lineage of K113229, 1992–2016Source: 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.

Planning a device in FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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
*	K081777	Ventrio Hernia Patch Summary page 1 …Antimicrobial Agent Classification Code: Class 11, § 878.3300, Product Code FTL Predicate Device Names: * Bard Ventrio Hernia Patch, KO081777 (Davol Inc.), FDA cleared on September 29,2008; K100229 - Special (Davol Inc.), FDA cleared on April 21,2010 * Pi…	C.R. Bard, Inc.	2008	4
*	K100229	Ventrio Hernia Patch Summary page 1 …Class 11, § 878.3300, Product Code FTL Predicate Device Names: * Bard Ventrio Hernia Patch, KO081777 (Davol Inc.), FDA cleared on September 29,2008; K100229 - Special (Davol Inc.), FDA cleared on April 21,2010 * Pivit AB Antimicrobial Mesh, K053656 (TyRx Pharma, Inc.), FDA clear…	C.R. Bard, Inc.	2010	—
*	K053656	Tyrx Antimicrobial Mesh Summary page 1 …tch, KO081777 (Davol Inc.), FDA cleared on September 29,2008; K100229 - Special (Davol Inc.), FDA cleared on April 21,2010 * Pivit AB Antimicrobial Mesh, K053656 (TyRx Pharma, Inc.), FDA cleared on July 14, 2006 * Pivit AB-ST Antimicrobial Mesh, K093524 (TyRx Pharma, Inc), F…	Tyrx Pharma, Inc.	2006	—
*	K093524	Pivit a/B ST and Pivit a/B ST-R Summary page 1 …leared on April 21,2010 * Pivit AB Antimicrobial Mesh, K053656 (TyRx Pharma, Inc.), FDA cleared on July 14, 2006 * Pivit AB-ST Antimicrobial Mesh, K093524 (TyRx Pharma, Inc), FDA cleared on March 26,20 10 PREMARKET NOTIFICATION FOR VENTRIoTH LIGHT HERNIA PATCH WI…	Tyrx, Inc.	2010	—

Also cleared against K081777: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133223	Xenmatrix AB Surgical Graft	C.R. Bard, Inc.	2014	2

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?

The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
7 of the 80 ancestors have a recall of any class.
Of its descendants, K133223 (C.R. Bard, Inc., 2014) has gone furthest, with 2 descendants of its own.
6 other devices also cite its predicate K081777.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

The VentrioTM Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113229 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113229

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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