Cleared Traditional

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

K250078 · Mindset Medical, Inc. · Cardiovascular

May 2025

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K250078 is an FDA 510(k) clearance for the Informed Vital Core Application (IVC App) (v2.0.0.2.0.0), 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 May 30, 2025, 137 days after receiving the submission on January 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2785.

Submission Details

510(k) Number	K250078 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2025
Decision Date	May 30, 2025
Days to Decision	137 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.