# K021736: Bard Ventralex Hernia Patch, Models 0010302, 0010301

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 16, 2002 after 49 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard Composix Kugel Mesh (Davol Inc.): named in the summary without a submission number

## Most influential descendants
- K024008: Small Bard Ventralex Patch (2003), 15 descendants of its own
- K120506: Parietex Composite Ventral Patch (2012), 11 descendants of its own
- K131969: Symbotex (TM) Composite Mesh (2013), 10 descendants of its own
- K142908: Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh (2014), 5 descendants of its own
- K150091: Versatex Monofilament Mesh (2015), 4 descendants of its own

## Recalls of this device
- Apr 11, 2011 · Not classified · Z-2124-2011: 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"

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

Source page: https://510kreport.com/device/K021736
Methodology: https://510kreport.com/methodology