510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223622Substantially Equivalent

FaceHeart Vitals Software Development Kit (FH vitals SDK)

Faceheart Corp., Grand Cayman, KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223622 is the FDA 510(k) clearance record for FaceHeart Vitals Software Development Kit (FH vitals SDK), a class II device, cleared for Faceheart Corp. on under FDA product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate). FDA's definition for product code QME reads: "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". FDA records list 2 510(k) clearances for Faceheart Corp., from to . As of , FDA records show no recalls naming K223622.

Clearance record

Decision date
Received
(270 days to decision)
Product code
QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Regulation
21 CFR 870.2785
Device class
Class II
Review panel
Cardiovascular
Applicant
Faceheart Corp. P.O. Box 309, Ugland House, Grand Cayman, KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QME

Trailing 12 months
4 clearances under product code QME in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QME, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260