Cleared Traditional

K223622 - FaceHeart Vitals Software Development K...

K223622 is an FDA 510(k) clearance for FaceHeart Vitals Software Development K..., manufactured by Faceheart Corp.. The device is a Class 2 Cardiovascular device with product code QME cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K223622 · Faceheart Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
270d
Days
Class 2
Risk

K223622 is an FDA 510(k) clearance for the FaceHeart Vitals Software Development Kit (FH vitals SDK). Classified as Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (product code QME), Class II - Special Controls.

Submitted by Faceheart Corp. (Grand Cayman, KY). The FDA issued a Cleared decision on September 1, 2023 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2785 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Faceheart Corp. devices

FDA 510(k) Submission Details - K223622

510(k) Number K223622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QME Device Classification - Class 2, Special Controls

Product Code QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

All 10
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K223622.
PanopticAI Vital Signs
K240890 · PanopticAI technologies Limited · Dec 2024
Informed Vital Core Application (IVC App)
K241633 · Mindset Medical, Inc. · Nov 2024
FibriCheck
K232804 · Qompium NV · Jun 2024
Oxehealth Vital Signs
K220899 · Oxehealth Limited · Apr 2022
Vital Signs
K211906 · Oxehealth Limited · Jul 2021
Oxehealth Vital Signs
DEN200019 · Oxehealth Limited · Mar 2021