# K250098: Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Apr 9, 2025 after 85 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: 1 generation back to K052155 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052155: Bard Large Pore Soft Mesh and Soft Mesh Preshaped, C.R. Bard, Inc. (2005) Summary page 5.

## Indications for use
Bard® Soft Mesh is indicated for the repair of ventral, incisional, and inguinal hernias. Bard® Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernias.

Source page: https://510kreport.com/device/K250098
Methodology: https://510kreport.com/methodology