The Circadia C300 System (C300)— 510(k) K261286

Substantially Equivalent

Circadia Health, Inc.

FDA 510(k) clearance K261286 for The Circadia C300 System (C300), Substantially Equivalent on 2026-05-20. Applicant: Circadia Health, Inc..

Clearance details

Applicant: Circadia Health, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2026-04-20
Decision date: 2026-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.