# K100821: Prevena Incision Management System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Jun 11, 2010 after 80 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
No predicates in its family tree.
67 later devices descend from it; 6 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ActiV.A.C. Therapy System: named in the summary without a submission number

## Most influential descendants
- K111170: PICO (2011), 26 descendants of its own
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit (2012), 25 descendants of its own
- K112127: Pico Single Use Negative Pressure Wound Therapy System (2012), 25 descendants of its own
- K151436: PICO Single Use Negative Pressure Wound Therapy System (2016), 23 descendants of its own
- K121883: Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit (2012), 14 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/K100821
Methodology: https://510kreport.com/methodology