# K090489: Abthera Open Abdomen Dressing, Model: M8275026

- Pathway: 510(k) (Special)
- Applicant: Kci USA, Inc.
- Decided: May 14, 2009 after 78 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: 3 generations back to K945062 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022011: V.a.C. Abdominal Dressing, Kinetic Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K120499: Abthera Open Abdomen Negative Pressure Therapy System (2012), 0 descendants of its own

## Indications for use
The ABThera Open Abdomen Dressing is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to, abdominal compartment syndrome. The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.

Source page: https://510kreport.com/device/K090489
Methodology: https://510kreport.com/methodology