Personalized Therapy Comfort Settings (PTCS)

Personalized Therapy Comfort Settings (PTCS) is an FDA 510(k)-cleared medical device (K251657) manufactured by Resmed Corp. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2025. Regulation: 8.