# K062227: V.a.C. Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Oct 4, 2006 after 63 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: 6 generations back to K914575 (1991). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032310: Mini V.a.C., V.a.C. Freedom, V.a.C. Ats, Kinetic Concepts, Inc. (2003) Summary page 1.
- K021501: V.a.C. Instillamat (Vacuum Assisted Closure Instillamat, Kinetic Concepts, Inc. (2002) Summary page 1.
- K053627: Modification to: V.a.C. Granufoam Silver Protection Dressing, Kci USA, Inc. (2006) Summary page 1.
- K022011: V.a.C. Abdominal Dressing, Kinetic Concepts, Inc. (2003) Summary page 1.

## Most influential descendants
- K083357: Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510 (2009), 1 descendant of its own
- K121817: Vcare a (2013), 0 descendants of its own
- K120499: Abthera Open Abdomen Negative Pressure Therapy System (2012), 0 descendants of its own

## Recalls of this device
- Jan 17, 2025 · Class II · Z-1176-2025: Due to increase in complaints related to leak alarms
- Nov 4, 2009 · Not classified · Z-0666-2010: Power cords may crack and fail inside plug with potential for fire hazard.

## Indications for use
The VAC. Therapy System 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 or pressure), flaps and grafts. The VAC. GranuFoam Silver Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

Source page: https://510kreport.com/device/K062227
Methodology: https://510kreport.com/methodology