# K190697: PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Nov 22, 2019 after 249 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 K945062 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173426: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System, Kci USA, Inc. (2018) Summary page 5.
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings, Kci USA, Inc. (Kinetic Concepts, Inc.) (2016) Summary page 5.

## Indications for use
The PREVENA PLUS Incision Management System (No Ag) 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. The PREVENA PLUS DUO Incision Management System (No Ag) 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/K190697
Methodology: https://510kreport.com/methodology