# K041923: Bioblanket

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Sep 8, 2004 after 54 days
- Product code: FTM (Mesh, Surgical)
- 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 K011025 (2001). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001) Summary page 1.

## Most influential descendants
- K043259: Bioblanket Surgical Mesh (2005), 10 descendants of its own
- K061030: Bioblanket Surgical Mesh (2006), 4 descendants of its own
- K091499: Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry) (2009), 3 descendants of its own
- K103787: Medeor Matrix (2011), 2 descendants of its own
- K082079: Regen Collagen Scaffold (CS) (2008), 2 descendants of its own

## Indications for use
BioBlanket Surgical Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists and for the repair of ruptured or damaged soft tissues. The device is intended for one time use.

Source page: https://510kreport.com/device/K041923
Methodology: https://510kreport.com/methodology