The Circadia C300 System (C300)

The Circadia C300 System (C300) is an FDA 510(k)-cleared medical device (K261286) manufactured by Circadia Health, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2026. Regulation: 8.