# K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: May 31, 2012 after 148 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: 1 generation back to K100821 (2010). 1 ancestor in all.
25 later devices descend from it; 6 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100821: Prevena Incision Management System, Kci USA, Inc. (2010) Summary page 1.

## Most influential descendants
- K133276: V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress (2013), 9 descendants of its own
- K181505: V.A.C. DERMATAC Drape (2019), 5 descendants of its own
- K183543: ACTIV.A.C. Therapy Unit (2019), 4 descendants of its own
- K132741: V.a.C. Via Negative Pressure Wound Therapy System (2013), 4 descendants of its own
- K201571: ACTIV.A.C. Negative Pressure Wound Therapy System (2020), 3 descendants of its own

## Indications for use
The ActiVAC., InfoVAC., V.AC. ATS, V.AC. Freedom, V.AC. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. When used on open wounds, they are 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. Open wound types include: chronic, acute, traumatic, subacute and dlehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, they are also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K120033
Methodology: https://510kreport.com/methodology