Nihon Kohden OrangeMed has received U.S. FDA 510(k) clearance for its NKV-330 Ventilator System.

The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. This system offers invasive and non-invasive ventilation, as well as high flow oxygen therapy. In addition, it provides continuous monitoring of CO2 when using the company’s cap-ONE NIV mask. The cap-ONE mask is 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 for adult and pediatric patients,” says Eiichi Tanaka, president and CEO of Nihon Kohden America. “This new platform offers a seamless transition between non-invasive therapy and high flow oxygen therapy to meet the changing needs of patients. The continuous monitoring of ETCO2, the excellent portability, dual HEPA filtration, ‘hot-swap’ battery, and many other features in the NKV-330 makes it a great choice for hospitals and healthcare providers.”

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.

Nihon Kohden is a manufacturer, developer, and distributor of medical electronic equipment, with subsidiaries in the U.S., Europe, Asia, and Latin America. The company’s products are now used in more than 120 countries, and supplies electroencephalography products worldwide. Nihon Kohden has envisioned, designed, and produced devices, such as pulse oximeters, arrhythmia analysis, low-invasive blood volume monitoring and wireless patient monitoring.