# K123878: Prevena Incision Management System with Customizable Dressing

- Pathway: 510(k) (Special)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Jan 15, 2013 after 29 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 8 (0 Class I)
- 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.
12 later devices descend from it; 2 cite it directly.
0 of 15 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 1.

## Most influential descendants
- K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, (2015), 10 descendants of its own
- 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 (2016), 9 descendants of its own
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (2016), 8 descendants of its own
- 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

## Recalls of this device
- Jan 30, 2014 · Class II · Z-1141-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1135-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1137-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1138-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1136-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1142-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1139-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
- Jan 30, 2014 · Class II · Z-1140-2014: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

## 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/K123878
Methodology: https://510kreport.com/methodology