510(k) K242485

EveryWare by Breas Medical AB — Product Code MOD

K242485 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "EveryWare". The FDA issued a decision of Substantially Equivalent on May 20, 2025. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Breas Medical AB has at least 10 other 510(k) clearances on record.