# K181507: PREVENA RESTOR (TM) Incision Management System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Feb 15, 2019 after 253 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: 9 generations back to K945062 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180855: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, Kci USA, Inc. (2018) Summary page 4.
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings, Kci USA, Inc. (Kinetic Concepts, Inc.) (2016) 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
- K220660: Prevena Restor Adapti-Form Dressing (2022), 0 descendants of its own

## Indications for use
The PREVENA RESTOR(TM) 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/K181507
Methodology: https://510kreport.com/methodology