Cleared Traditional

The Circadia C300 System (C300)

K252676 · Circadia Health, Inc. · Cardiovascular

Feb 2026

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K252676 is an FDA 510(k) clearance for the The Circadia C300 System (C300), 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 review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K252676 FDA.gov
FDA Decision	Cleared 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