# K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Oct 4, 2016 after 85 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: 6 generations back to K945062 (1995). 11 ancestors in all.
8 later devices descend from it; 4 cite 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)
- K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing,, Kci USA, Inc. (Kinetic Concepts, Inc.) (2015) Summary page 4.
- K153199: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack, Kci USA, Inc. (2016) Summary page 4.

## Most influential descendants
- K173426: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System (2018), 7 descendants of its own
- K180855: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System (2018), 5 descendants of its own
- K181507: PREVENA RESTOR (TM) Incision Management System (2019), 1 descendant of its own
- K223263: Prevena Plus 125 Therapy Unit (2023), 0 descendants of its own
- K220660: Prevena Restor Adapti-Form Dressing (2022), 0 descendants of its own

## Indications for use
The PREVENA DUO 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. The PREVENA PLUS DUO 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/K161897
Methodology: https://510kreport.com/methodology