# K082311: Exsudex Wound Drainage Pump

- Pathway: 510(k) (Abbreviated)
- Applicant: The Medical Company
- Decided: Oct 8, 2008 after 56 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: 3 generations back to K945062 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992448: V.a.C. Plus, Kinetic Concepts, Inc. (2000) Summary page 2.
- K971548: Ambuvac, Kinetic Concepts, Inc. (1997) Summary page 2.
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 2.
- K052456: Modification to Versatile 1 Wound Vacuum System, Blue Sky Medical Group Incorporated (2005) Summary page 2.

## Indications for use
The Exsudex™ Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient's bedside particularly as the device may promote wound healing .

Source page: https://510kreport.com/device/K082311
Methodology: https://510kreport.com/methodology