# K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

- Pathway: 510(k) (Traditional)
- Applicant: Cork Medical
- Decided: Jun 27, 2025 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: 7 generations back to K945062 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140022: Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT Canister 500-ML, Cork Medical Product, Cork Medical Products, LLC (2014) Summary page 5.

## Most influential descendants
- K261291: Nisus NPWT Canister 500-mL (CPC-500) (2026), 0 descendants of its own

## Indications for use
The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management. The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) The Nisus ONE Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

Source page: https://510kreport.com/device/K243187
Methodology: https://510kreport.com/methodology