510(k) · Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK)

by FaceHeart Corp.

FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-enabled medical device from FaceHeart Corp. that the U.S. FDA cleared through 510(k) K223622 on September 1, 2023. Its lead review panel is Cardiovascular and its primary product code is QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate).

See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.

Key facts

Submission numberK223622
Pathway510(k)
Date of final decision
Company (FDA list)FaceHeart Corp.
Lead review panelCardiovascular
Primary product codeQME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Applicant (openFDA)Faceheart Corp.
Applicant locationGrand Cayman, KY
Device classClass 2
Regulation number21 CFR 870.2785
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. FaceHeart Vitals Software Development Kit (FH vitals SDK) went through this pathway (K223622).

openFDA lists it as a Class 2 device under 21 CFR 870.2785. Class II devices are moderate risk and are subject to general and special controls.

Product code QME covers 7 devices on the FDA AI list. By decision date, this device is #4 of 7 under that code. FaceHeart Corp. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code QME)