# K162610: NEXA Negative Pressure Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Medical, Ltd.
- Decided: Jun 8, 2017 after 262 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132741: V.a.C. Via Negative Pressure Wound Therapy System, Kci USA, Inc. (2013) Summary page 5.

## Indications for use
The NEXA NPWT system is intended for patients who may benefit from the application of negative pressure to the wound to promote wound healing through the removal of excess exudate, infectious material and tissue debris. It is intended for use in long-term care and acute settings only when prescribed by a Health Care Professional. Appropriate wound types include: • Chronic wounds • Pressure ulcers • Diabetic foot ulcers • Venous leg ulcers

Source page: https://510kreport.com/device/K162610
Methodology: https://510kreport.com/methodology