Cleared Traditional

FaceHeart Vitals Software Development Kit (FH vitals SDK)

K223622 · Faceheart Corp. · Cardiovascular

Sep 2023

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K223622 is an FDA 510(k) clearance for the FaceHeart Vitals Software Development Kit (FH vitals SDK), a Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (Class II — Special Controls, product code QME), submitted by Faceheart Corp. (Grand Cayman, KY). The FDA issued a Cleared decision on September 1, 2023, 270 days after receiving the submission on December 5, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K223622 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2022
Decision Date	September 01, 2023
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QME — Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2785
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.