510(k) K242438

Clearo by Breas Medical AB — Product Code NHJ

K242438 is an FDA 510(k) premarket notification submitted by Breas Medical AB for the device "Clearo". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Breas Medical AB has at least 10 other 510(k) clearances on record.