# K122490: Kulavac

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: Nov 13, 2013 after 455 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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 2.
- K082211: Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits, Smith & Nephew, Inc. (2008)

## Indications for use
KulaVAC Foam Dressing Kit is intended to be used in conjunction with suction devices to deliver negative pressure wound therapy to the wound. KulaVAC Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Source page: https://510kreport.com/device/K122490
Methodology: https://510kreport.com/methodology