FDA Product Code QOK: Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate
The Device Uses An Optical Sensor System And Software Algorithms To Obtain And Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device Is Not Intended To Independently Direct Therapy.
Leading manufacturers include Continuse Biometrics , Ltd. and Neko Health AB.
2
Total
1
Cleared
280d
Avg days
2021
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
267d avg (recent)
FDA 510(k) Cleared Hardware And Software For Optical Camera-based Measurement Of Heart Rate And Respiratory Rate Devices (Product Code QOK)
2 devices
Cleared
Sep 22, 2026
Echo-2
Neko Health AB
Cardiovascular
267d
Not Cleared
Apr 01, 2021
Gili Pro BioSensor (also known as “Gili BioSensor System”)
Continuse Biometrics , Ltd.
Cardiovascular
293d
About Product Code QOK - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QOK since 2021, with 1 receiving FDA clearance (average review time: 280 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QOK Product Code
FDA review times for QOK submissions have been consistent, averaging 267 days recently vs 293 days historically.
QOK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →