# K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Oct 10, 2003 after 74 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945062 (1995). 3 ancestors in all.
112 later devices descend from it; 14 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992448: V.a.C. Plus, Kinetic Concepts, Inc. (2000) Summary page 1.
- K971548: Ambuvac, Kinetic Concepts, Inc. (1997) Summary page 1.

## Most influential descendants
- K080357: Medela Invia Wound Therapy (2008), 75 descendants of its own
- K063692: V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 (2007), 60 descendants of its own
- K083375: Renasys GO Negative Pressure Wound Therapy (2009), 56 descendants of its own
- K080275: NPD 1000 Negative Pressure Wound Therapy System (2008), 37 descendants of its own
- K111170: PICO (2011), 26 descendants of its own

## Recalls of this device
- Sep 16, 2005 · Not classified · Z-0379-06: Possible mislabeling of shipping cartons.
- Sep 21, 2004 · Not classified · Z-0038-05: The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

## Indications for use
The V.A.C.® family of devices with wound site feedback control are negative pressure devices used to help promote wound healing. through means including drainage and removal of infectious material or other fluids. under the Influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Feedback control is achieved by measuring the level of negative pressure at the wound site.

Source page: https://510kreport.com/device/K032310
Methodology: https://510kreport.com/methodology