# K111280: V.a.C. 125 Negative Pressure Wound Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Jul 21, 2011 after 76 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K060369: Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak, Dade Behring, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The V.AC. Simplicity Tm Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts

Source page: https://510kreport.com/device/K111280
Methodology: https://510kreport.com/methodology