# K251955: Onflex™ Mesh

- Pathway: 510(k) (Special)
- Applicant: Davol Inc., Subsidiary of C. R. Bard, Inc.
- Decided: Jul 24, 2025 after 29 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: 5 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)
- K142711: ONFLEX Mesh, C.R. Bard, Inc. (2015) Summary page 5.

## Indications for use
The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

Source page: https://510kreport.com/device/K251955
Methodology: https://510kreport.com/methodology