The US FDA issued 510(k) clearance for the NKV-330 Ventilator System, according to Nihon Kohden OrangeMed, the R&D/Manufacturing branch for mechanical ventilation for Nihon Kohden.

The NKV-330 is a noninvasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only noninvasive ventilation but also invasive ventilation as well as high flow oxygen therapy. In addition, it provides continuous monitoring of CO2 when using Nihon Kohden’s cap-One NIV mask — an NIV interface that allows quality CO2 monitoring directly from the ventilator.

“The NKV-330 ventilator can help hospitals who face a limited choice of new non-invasive ventilator platforms.” said Dr. Hong-Lin Du, CEO of Nihon Kohden OrangeMed. “The continuous monitoring of CO2, the excellent portability, and many other features in the NKV-330 makes it a great choice for the hospitals and caregivers.”

The NKV-330 Ventilator System is distributed in the United States by Nihon Kohden America Inc and is expected to begin shipping in July 2022. It has been available outside of the United States since 2019.

About Nihon Kohden OrangeMed Inc

Nihon Kohden OrangeMed, located in Orange County, California, focuses on design, development, and providing state-of-the-art innovative respiratory products distributed throughout the Nihon Kohden worldwide distribution network.

Nihon Kohden OrangeMed is part of Nihon Kohden Corporation headquartered in Tokyo, Japan. Nihon Kohden is one of the leaders in medical device design and manufacturing in the world. Listed on the Tokyo Stock Exchange, Nihon Kohden, with its 5,000 employees, tirelessly pursues to deliver medical technology innovations and high-quality medical products worldwide. Nihon Kohden’s products range from bedside monitors, central monitors, defibrillators, AEDs, physiological measuring equipment, in vitro diagnostic equipment, and mechanical ventilators. Nihon Kohden has superior brand strength with over 70 years of advancing medical care through technological breakthroughs.