# K261291: Nisus NPWT Canister 500-mL (CPC-500)

- Pathway: 510(k) (Special)
- Applicant: Cork Medical
- Decided: May 21, 2026 after 31 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: 8 generations back to K945062 (1995). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100), Cork Medical (2025) Summary page 5.

## Indications for use
The Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management. The Cork NPWT System and Nisus Touch Negative Pressure Wound Therapy Pump is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) The systems consist of a negative pressure wound therapy unit, dressings, tubing, and disposable canisters, including available canister configurations up to 500 mL capacity.

Source page: https://510kreport.com/device/K261291
Methodology: https://510kreport.com/methodology