𝗧𝗲𝗹𝗲𝘀𝗮𝗶𝗿, 𝗜𝗻𝗰. 𝗥𝗲𝗰𝗲𝗶𝘃𝗲𝘀 𝗙𝗗𝗔 𝟱𝟭𝟬(𝗸) 𝗖𝗹𝗲𝗮𝗿𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗗𝗶𝘀𝗽𝗼𝘀𝗮𝗯𝗹𝗲 𝗔𝘃𝗲𝗮 𝗘𝘅𝗽𝗶𝗿𝗮𝘁𝗼𝗿𝘆 𝗙𝗶𝗹𝘁𝗲𝗿 𝗮𝗻𝗱 𝗪𝗮𝘁𝗲𝗿 𝗧𝗿𝗮𝗽

𝗜𝗥𝗩𝗜𝗡𝗘, 𝗖𝗔 – 𝗠𝗮𝘆 𝟴𝘁𝗵, 𝟮𝟬𝟮𝟱 – Telesair, Inc., an innovator in respiratory care technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the disposable Avea™ expiratory filter and water trap.

This regulatory clearance is a significant step following Telesair's acquisition of the Avea™ filter business from Vyaire Medical earlier this year. The clearance ensures the continued availability of this critical components for the widely used Vyaire Avea™ ventilator system.

The Avea™ expiratory filter and water trap are essential single-use accessories designed to protect both the patient and the ventilator hardware by effectively filtering expired gases and managing condensate during mechanical ventilation. Continued access to these FDA-cleared components is vital for hospitals and healthcare facilities relying on the Avea™ ventilator platform to treat critically ill patients.

"Securing FDA 510(k) clearance for the Avea™ expiratory filter and water trap underscores Telesair's commitment to supporting patients and clinicians," said Dr. Don Lin, CEO. "When we acquired this product line, our priority was to ensure a seamless transition for the hospitals that depend on the Avea™ system. This clearance allows us to fulfill that commitment, helping to maintain high standards of care for vulnerable patients."

The acquisition and subsequent FDA clearance by Telesair prevent potential disruptions in the supply chain for these necessary ventilator accessories, allowing healthcare providers to continue utilizing their existing Vyaire Avea™ ventilator fleets.

𝗔𝗯𝗼𝘂𝘁 𝗧𝗲𝗹𝗲𝘀𝗮𝗶𝗿, 𝗜𝗻𝗰. Telesair, Inc., based in Irvine, California, is an innovator in the respiratory care market, dedicated to developing advanced technology solutions to improve patient outcomes and support clinicians worldwide. The company focuses on creating high-quality, reliable medical devices for critical care environments.

For further information regarding the Avea filter please contact Avea_filter@telesair.com