FDA Product Code QME: Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
The Device Uses Software Algorithms To 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 Oxehealth Limited, Mindset Medical, Inc. and Faceheart Corp..
FDA 510(k) Cleared Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate Devices (Product Code QME)
About Product Code QME - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code QME since 2021, with 9 receiving FDA clearance (average review time: 209 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QME have taken an average of 233 days to reach a decision - up from 174 days historically. Manufacturers should account for longer review timelines in current project planning.
QME devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →