FDA grants 510(k) clearance to high-flow oxygen therapy system

The FDA granted 510(k) clearance to the Bonhawa High Flow Oxygen Therapy system for patients with respiratory insufficiency, according to a manufacturer-issued press release.

Key features of the Bonhawa (Telesair) system that aid both patients and those working in health care include its lightweight design, touchscreen, bright display, large flow range of up to 80 L per minute and efficient disinfection process, according to the release.

Prior to this clearance, the product received CE marking under the European Medical Device Regulation.

“The best-in-class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” Bryan Liu, PhD, Telesair’s CEO, said in the release. “It represents a significant milestone in that it is a more cost-effective, user-friendly option for treating respiratory conditions. Bonhawa is the only standalone high-flow oxygen therapy system designed by experts in ventilation. Our team has decades of experience developing and commercializing revolutionary respiratory solutions and collaborated to create this efficient, easy-to-use system.”

Reference:

• Telesair. https://www.telesair.com/. Accessed Oct. 17, 2023.