# K102956: V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C. Granufoam Silver Large Dressing

- Pathway: 510(k) (Special)
- Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decided: Dec 15, 2010 after 72 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: 6 generations back to K914575 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053627: Modification to: V.a.C. Granufoam Silver Protection Dressing, Kci USA, Inc. (2006) Summary page 1.

## Indications for use
The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in 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/K102956
Methodology: https://510kreport.com/methodology