# K253199: Curasys 2 (EMDN0003)

- Pathway: 510(k) (Traditional)
- Applicant: CG Bio Co., Ltd.
- Decided: Jun 23, 2026 after 270 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: 6 generations back to K945062 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201571: ACTIV.A.C. Negative Pressure Wound Therapy System, Kci USA, Inc. (2020) Summary page 5.

## Indications for use
The CURASYS 2 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for use in acute and extended care settings. 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. When used on closed surgical incisions, it is 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/K253199
Methodology: https://510kreport.com/methodology