Cleared Traditional

Informed Vital Core Application (IVC App)

K241633 · Mindset Medical, Inc. · Cardiovascular

Nov 2024

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K241633 is an FDA 510(k) clearance for the Informed Vital Core Application (IVC App), 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 Mindset Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 18, 2024, 165 days after receiving the submission on June 6, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K241633 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2024
Decision Date	November 18, 2024
Days to Decision	165 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.