K252676 is an FDA 510(k) clearance for the The Circadia C300 System (C300). This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Circadia Health, Inc. (El Segundo, US). The FDA issued a Cleared decision on February 3, 2026, 162 days after receiving the submission on August 25, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K252676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2025 |
| Decision Date | February 03, 2026 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRT - Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |