# K053627: Modification to: V.a.C. Granufoam Silver Protection Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Feb 6, 2006 after 39 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: 5 generations back to K914575 (1991). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050261: V.a.C. Granufoam Silver Protection Dressing, Kinetic Concepts, Inc. (2005). Our reading of the summary gave K050260, FDA’s number for Bioresorb Macro Pore (Oraltronics Dental Implant Technology GmbH). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “V.A.C.® GranuFoam® Silver Protection dressing”. Summary page 1.

## Most influential descendants
- 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
- K121817: Vcare a (2013), 0 descendants of its own
- K120499: Abthera Open Abdomen Negative Pressure Therapy System (2012), 0 descendants of its own
- K102956: V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C. Granufoam Silver Large Dressing (2010), 0 descendants of its own

## 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, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.

Source page: https://510kreport.com/device/K053627
Methodology: https://510kreport.com/methodology