# K083357: Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Mar 4, 2009 after 111 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914575 (1991). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 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.
- K062227: V.a.C. Therapy System, Kci USA, Inc. (Kinetic Concepts, Inc.) (2006) Summary page 1.

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

## Indications for use
The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system 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/K083357
Methodology: https://510kreport.com/methodology