510(k) K251419

Laboratorios Biogalenic Sterile Water for Inhalation, USP by Laboratorios Biogalenic S.A. DE C.V. — Product Code BTT

K251419 is an FDA 510(k) premarket notification submitted by Laboratorios Biogalenic S.A. DE C.V. for the device "Laboratorios Biogalenic Sterile Water for Inhalation, USP". The FDA issued a decision of Substantially Equivalent on January 14, 2026. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Laboratorios Biogalenic S.A. DE C.V. has at least 2 other 510(k) clearances on record.