# K063740: V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Jun 7, 2007 after 171 days
- Product code: OMP (Negative Pressure Wound Therapy Powered Suction Pump)
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945062 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K063426: V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10, Kci USA, Inc. (2006) Summary page 1.

## Most influential descendants
- K160487: V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System (2016), 0 descendants of its own

## Recalls of this device
- Apr 28, 2017 · Class II · Z-2171-2017: Potential sterile barrier breach
- Nov 4, 2009 · Not classified · Z-0666-2010: Power cords may crack and fail inside plug with potential for fire hazard.
- Jul 29, 2008 · Not classified · Z-2440-2008: The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.
- Jul 29, 2008 · Not classified · Z-2439-2008: The port on the 500mL InfoV.A.C. Canister that connects to the suction pump tubing was found to be partially or fully occluded with plastic.

## Indications for use
The V.A.C.® 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 or pressure), flaps and grafts. The V.A.C.® 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/K063740
Methodology: https://510kreport.com/methodology