510(k) K251657

Personalized Therapy Comfort Settings (PTCS) by Resmed Corp — Product Code BZD

K251657 is an FDA 510(k) premarket notification submitted by Resmed Corp for the device "Personalized Therapy Comfort Settings (PTCS)". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Resmed Corp has at least 10 other 510(k) clearances on record.