DeltaWave Nasal Pillow System

DeltaWave Nasal Pillow System is an FDA 510(k)-cleared medical device (K253939) manufactured by RemSleep Holdings, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2026. Regulation: 8.