# K261286: The Circadia C300 System (C300)

- Pathway: 510(k) (Special)
- Applicant: Circadia Health, Inc.
- Decided: May 20, 2026 after 30 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K830295 (1983). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252676: The Circadia C300 System (C300), Circadia Health, Inc. (2026) Summary page 5.

## Indications for use
The Circadia C300 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities, and in the home environment. The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute life-threatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended to be reviewed by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits).

Source page: https://510kreport.com/device/K261286
Methodology: https://510kreport.com/methodology