510(k) K251133

AVEA disposable expiratory filter/water trap (11790) by Telesair, Inc. — Product Code CBK

K251133 is an FDA 510(k) premarket notification submitted by Telesair, Inc. for the device "AVEA disposable expiratory filter/water trap (11790)". The FDA issued a decision of Substantially Equivalent on May 8, 2025. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Telesair, Inc. has at least 1 other 510(k) clearance on record.