# K132441: Bard Ventralex Hernia Patch

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 13, 2013 after 129 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003323 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021736: Bard Ventralex Hernia Patch, Models 0010302, 0010301, C.R. Bard, Inc. (2002) Summary page 1.
- K024008: Small Bard Ventralex Patch, C.R. Bard, Inc. (2003) Summary page 1.
- K081777: Ventrio Hernia Patch, C.R. Bard, Inc. (2008) Summary page 1.
- K100229: Ventrio Hernia Patch, C.R. Bard, Inc. (2010) Summary page 1.

## Indications for use
The Bard® Ventralex™ Hernia Patch is intended for use in all forms of hernia repair requiring reinforcement with a nontabsorbable support material. The small Bard® Ventralex™ Hernia Patch (4.3 cm / 1.7") is also intended to repair soft tissue deficiencies, including deficiencies caused by trocars.

Source page: https://510kreport.com/device/K132441
Methodology: https://510kreport.com/methodology