DeviceClearance

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.. Device class: 2.

Summary

Circadia Health's record names the device "The Circadia C300 System (C300)". It's filed under DRT, cardiac monitors, including cardiotachometers and rate alarms.

Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Circadia filed from El Segundo, California. Review took 30 calendar days (April 20 to May 20, 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
Special
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DRT

view all

Adverse 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.