QME · Class II · 21 CFR 870.2785

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, PanopticAI technologies Limited and Mindset Medical, Inc..

13
Total
12
Cleared
200d
Avg days
2021
Since
Growing category - 8 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 205d avg (recent)

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)

13 devices
1–13 of 13
Cleared May 21, 2026
PanopticAI Vital Signs (1.6.1-22)
K260066
PanopticAI technologies Limited
Cardiovascular · 132d
Cleared Feb 02, 2026
Vital Signs
K251200
Oxehealth Limited
Cardiovascular · 290d
Cleared Aug 27, 2025
Vital Signs
K243687
Oxehealth Limited
Cardiovascular · 271d
Cleared May 30, 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078
Mindset Medical, Inc.
Cardiovascular · 137d
Cleared Dec 23, 2024
PanopticAI Vital Signs
K240890
PanopticAI technologies Limited
Cardiovascular · 266d
Cleared Nov 18, 2024
Informed Vital Core Application (IVC App)
K241633
Mindset Medical, Inc.
Cardiovascular · 165d
Cleared Jun 07, 2024
FibriCheck
K232804
Qompium NV
Cardiovascular · 269d
Cleared Sep 01, 2023
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622
Faceheart Corp.
Cardiovascular · 270d
Cleared Apr 29, 2022
Oxehealth Vital Signs
K220899
Oxehealth Limited
Cardiovascular · 32d
Cleared Jul 20, 2021
Vital Signs
K211906
Oxehealth Limited
Cardiovascular · 29d
Not Cleared Mar 26, 2021
Oxehealth Vital Signs
DEN200019
Oxehealth Limited
Cardiovascular · 364d

About Product Code QME - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code QME since 2021, with 12 receiving FDA clearance (average review time: 200 days).

Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QME Product Code

FDA review times for QME submissions have been consistent, averaging 205 days recently vs 193 days historically.

QME devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →