510(k) · Cleared

Recalled · 2011

Bard Ventralex Hernia Patch, Models 0010302, 0010301

K021736510(k) TraditionalCleared Jul 16, 200249-day reviewClass II21 CFR 878.3300Recalls 1

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 16, 2002 after a 49-day review. The FDA summary names its predicate without a number. 17 later devices descend from it. It has been recalled once.

Decided: Jul 16, 2002
Review: 49 days
Class: Class II
Product code: FTL
Recalls: 1
Predicates: 0

17 later devices descend from it, 5 citing it directly.

This deviceK021736 Bard Ventralex Hernia Patch, Models 0010302, 0010301C.R. Bard, Inc. · 2002
Descendant · cites it directly · 15 of its ownK024008 Small Bard Ventralex PatchC.R. Bard, Inc. · 2003
Descendant · cites it directly · 11 of its ownK120506 Parietex Composite Ventral PatchSofradim Production · 2012
Descendant · 2 generations on · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
Descendant · 2 generations on · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
Descendant · 3 generations on · 4 of its ownK150091 Versatex Monofilament MeshSofradim Production · 2015 · Recalled

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003high 3 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 17 · See all

K024008Small Bard Ventralex PatchC.R. Bard, Inc. · 2003 · cites it directly15descendants
K120506Parietex Composite Ventral PatchSofradim Production · 2012 · cites it directly11descendants
K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · 2 generations on10descendants
K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · 2 generations on5descendants
K150091Versatex Monofilament MeshSofradim Production · 2015 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021736	Bard Ventralex Hernia Patch, Models 0010302, 0010301	C.R. Bard, Inc.	2002	—
+1	K024008	Small Bard Ventralex Patch	C.R. Bard, Inc.	2003	—
+1	K120506	Parietex Composite Ventral Patch	Sofradim Production	2012	—
+2	K131969	Symbotex (TM) Composite Mesh	Sofradim Production	2013	—
+2	K142908	Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)…	Sofradim Production	2014	1
+3	K150091	Versatex Monofilament Mesh	Sofradim Production	2015	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2010	1	0
2011	1	0
2012	1	0
2013	3	0
2014	2	0
2015	1	0
2018	1	0
2022	2	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K021736, 2002–2026Source: 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.

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

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What was it cleared against? (1)

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
*	—	Bard Composix Kugel Mesh (Davol Inc.) Named without a submission number			—

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K024008	Small Bard Ventralex Patch	C.R. Bard, Inc.	2003	15
K120506	Parietex Composite Ventral Patch	Sofradim Production	2012	11
K101928	Ventralex ST Hernia Patch	C.R. Bard, Inc.	2011	1
K132441	Bard Ventralex Hernia Patch	C.R. Bard, Inc.	2013	0
K093196	Biomesh CA.B.S. 'Air Composite, Models: CABST1R05T, CABSAIRC7, CABSAIRC09	Cousin Biotech Sas	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 11, 2011	Not classified	Z-2124-2011	Labeling mix-ups	Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7"

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K024008 (C.R. Bard, Inc., 2003) has gone furthest, with 15 descendants of its own.

How does its category compare?

All FTL devices

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

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?

Intended for the use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021736 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021736: Bard Ventralex Hernia Patch, Models 0010302, 0010301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021736

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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