# K150006: Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Nov 6, 2015 after 308 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: 2 generations back to K100821 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121883: Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit, Kci USA, Inc. (Kinetic Concepts, Inc.) (2012) Summary page 4.

## Indications for use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K150006
Methodology: https://510kreport.com/methodology