# K241515: NEXA™ NPWT System

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Medical Limited
- Decided: Jul 26, 2024 after 58 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™ Negative Pressure Wound Therapy System (NEXA™ NPWT) is intended for patients who may benefit from the application of negative pressure wound therapy to promote wound healing through the removal of excess exudates, infectious material and the promotion of granulation tissue. It is intended for use in acute, extended and home care settings only when prescribed by a Health Care Professional. Appropriate wound types include: • Chronic wounds • Pressure ulcers • Diabetic foot ulcers • Venous leg ulcers • Acute wounds • Surgical incisional wounds • Subacute and dehisced wounds • Partial thickness burns, flaps and grafts

Source page: https://510kreport.com/device/K241515
Methodology: https://510kreport.com/methodology