# K021500: Vacuum Assisted Closure

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Concepts, Inc.
- Decided: Dec 20, 2002 after 225 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: 2 generations back to K945062 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945062: Vacplus, Kinetic Concepts, Inc. (1995) Summary page 1.
- K992448: V.a.C. Plus, Kinetic Concepts, Inc. (2000) Summary page 1.

## Indications for use
The V.A.C.® System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures. "The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.

Source page: https://510kreport.com/device/K021500
Methodology: https://510kreport.com/methodology