# K193144: T-Line Hernia Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Deep Blue Medical Advances, Inc.
- Decided: Mar 30, 2020 after 138 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.
3 later devices descend from it; 3 cite it directly.
0 of 5 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 4.

## Most influential descendants
- K221556: T-Line Hernia Mesh (2022), 2 descendants of its own
- K230227: T-Line Hernia Mesh (2023), 1 descendant of its own
- K232924: T-Line® Hernia Mesh (2023), 0 descendants of its own

## Indications for use
T-LINE™ HERNIA MESH is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay approach.

Source page: https://510kreport.com/device/K193144
Methodology: https://510kreport.com/methodology