DeviceClearance

Product code QME— Cardiovascular

Vital Signs

Classification name
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Device class
Class 2
Regulation
21 CFR 870.2785
Advisory panel
Cardiovascular
Total cleared
13
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QME under 21 CFR 870.2785, via openFDA

Market context for product code QME

FDA has cleared 13 devices under product code QME between 2021 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QME

Recent clearances under product code QME

Data sourced from openFDA. This site is unofficial and independent of the FDA.