# K922916: Bard Marlex Mesh Dart

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 24, 1992 after 68 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
No predicates in its family tree.
133 later devices descend from it; 11 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh (2000), 113 descendants of its own
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), 80 descendants of its own
- K033636: Ams Large Pore Polypropylene Mesh (2003), 79 descendants of its own
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), 74 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own

Source page: https://510kreport.com/device/K922916
Methodology: https://510kreport.com/methodology