# K041642: V.a.C. Granufoam Silver Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Jan 25, 2005 after 222 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: 3 generations back to K945062 (1995). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 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.
- K001519: Acticoat 7 Dressing, Westaim Biomedical, Inc. (2000) Summary page 1.

## Most influential descendants
- K050261: V.a.C. Granufoam Silver Protection Dressing (2005), 7 descendants of its own
- K053627: Modification to: V.a.C. Granufoam Silver Protection Dressing (2006), 5 descendants of its own
- K062227: V.a.C. Therapy System (2006), 3 descendants of its own
- K083357: Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510 (2009), 1 descendant of its own
- K141033: Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound Contact Negativ (2014), 0 descendants of its own

## Indications for use
The V.A.C. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.

Source page: https://510kreport.com/device/K041642
Methodology: https://510kreport.com/methodology