# K200445: The C100 Contactless Breathing Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Circadia Technologies, Ltd.
- Decided: Jun 24, 2020 after 121 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913396 (1992). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103631: Sleepminder Breathing Frequency Indicator, Biancamed Limited (2011) Summary page 5.

## Indications for use
The Circadia C 100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel. The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider. The Circadia C 100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor

Source page: https://510kreport.com/device/K200445
Methodology: https://510kreport.com/methodology