# K160487: V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System

- Pathway: 510(k) (Traditional)
- Applicant: Kci USA, Inc.
- Decided: Dec 9, 2016 after 291 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 K945062 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063740: V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766, Kci USA, Inc. (2007) Summary page 4.
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit, Kci USA, Inc. (2012) Summary page 8.

## Indications for use
The V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional. When used on open wounds, 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. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), 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. When used on closed surgical incisions, it is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Source page: https://510kreport.com/device/K160487
Methodology: https://510kreport.com/methodology