# K203693: Nisus Touch Negative Pressure Wound Therapy Pump

- Pathway: 510(k) (Traditional)
- Applicant: Cork Medical Products, LLC
- Decided: Aug 13, 2021 after 238 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.
No later device cites it as a predicate yet.
0 of 13 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 4.

## Indications for use
The 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 may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Source page: https://510kreport.com/device/K203693
Methodology: https://510kreport.com/methodology