# K121817: Vcare a

- Pathway: 510(k) (Traditional)
- Applicant: IVT Medical, Ltd.
- Decided: Sep 17, 2013 after 454 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: 7 generations back to K914575 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062227: V.a.C. Therapy System, Kci USA, Inc. (Kinetic Concepts, Inc.) (2006) Summary page 1.

## Indications for use
The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness bums, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.

Source page: https://510kreport.com/device/K121817
Methodology: https://510kreport.com/methodology