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C100 Contactless Breathing Monitor

by Circadia Technologies, Ltd.

510(k) K200445

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200445 Date24 Jun 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
The C100 Contactless Breathing Monitor
510(k) Number
FDA Product Code
BZQ
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The C100 Contactless Breathing Monitor is a device that detects a patient's respiratory rate and sends notifications when respiratory rate values deviate from normal bands with medical-grade accuracy. It 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 C100 Contactless Breathing Monitor is manufactured by Circadia Technologies, Ltd. and has received FDA 510(k) clearance with the K200445 number. The device is designed for use in medical settings and is intended to be used as part of a vital signs assessment. It is not specified whether the device is single-use or reusable, nor are specific sizes or MRI safety information provided in the data.

Other devices from Circadia Technologies, Ltd.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the C100 Contactless Breathing Monitor used for?

    The C100 Contactless Breathing Monitor is designed to detect a patient's respiratory rate and send notifications when values deviate from normal bands with medical-grade accuracy. It is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment.

  • How is the C100 Contactless Breathing Monitor supplied?

    The device is manufactured by Circadia Technologies, Ltd. and is designed for use in medical settings. The data does not specify whether the device is single-use or reusable, nor does it provide information about specific sizes or MRI safety.

  • What regulatory approval does the C100 Contactless Breathing Monitor have?

    The C100 Contactless Breathing Monitor has received FDA 510(k) clearance with the K200445 number. It is classified as a Class II device and is substantially equivalent to other devices in its category, specifically in the Anesthesiology medical specialty.

  • How does the C100 Contactless Breathing Monitor handle respiratory data?

    The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. It provides medical-grade accuracy for monitoring respiratory rates and alerts when values fall outside normal parameters.