# K120499: Abthera Open Abdomen Negative Pressure Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Oct 5, 2012 after 227 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: 8 generations back to K914575 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090489: Abthera Open Abdomen Dressing, Model: M8275026, Kci USA, Inc. (2009) Summary page 1.
- K083357: Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510, Kci USA, Inc. (2009) Summary page 1.

## Indications for use
The AB Thera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal well openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this system is in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

Source page: https://510kreport.com/device/K120499
Methodology: https://510kreport.com/methodology