# K052155: Bard Large Pore Soft Mesh and Soft Mesh Preshaped

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 20, 2005 after 73 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.
21 later devices descend from it; 4 cite it directly.
0 of 22 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 Mesh (Davol Inc.): named in the summary without a submission number
- (no number) Ethicon Mersilene Polyester Fiber Mesh (Ethicon, Inc.): named in the summary without a submission number
- (no number) Ethicon Prolene Soft Polypropylene Mesh (Ethicon, Inc.): named in the summary without a submission number

## Most influential descendants
- K061754: Bard Composite L/P Mesh (2006), 14 descendants of its own
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), 7 descendants of its own
- K102766: Composix L/P Mesh with Echo PS Positioning System (2010), 6 descendants of its own
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own

## Recalls of this device
- Oct 15, 2010 · Not classified · Z-0446-2011: Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).

## Indications for use
Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

Source page: https://510kreport.com/device/K052155
Methodology: https://510kreport.com/methodology