The Circadia C300 System (C300)— 510(k) K252676
Substantially EquivalentCircadia Health, Inc.
FDA 510(k) clearance K252676 for The Circadia C300 System (C300), Substantially Equivalent on 2026-02-03. Applicant: Circadia Health, Inc.. Device class: 2.
Summary
Circadia Health filed The Circadia C300 System (C300) under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Circadia Health filed from El Segundo, California. The substantially equivalent decision came 162 calendar days after receipt (August 25, 2025 to February 3, 2026).
Clearance details
- Applicant
- Circadia Health, Inc.
- Product code
- Product code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Segundo, CA, US
Recent devices under product code DRT
view allAdverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . 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.