Cleared Traditional

K250078 - Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K250078 · Mindset Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
137d
Days
Class 2
Risk

K250078 is an FDA 510(k) clearance for the Informed Vital Core Application (IVC App) (v2.0.0.2.0.0). 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 Mindset Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on May 30, 2025 after a review of 137 days - within the typical 510(k) review window.

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 Mindset Medical, Inc. devices

Submission Details

510(k) Number K250078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

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 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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06508047 Completed Observational Industry-sponsored

Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

68
Patients (actual)
1
Site
Condition studied Vital Sign Evaluation
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Monica Rabanal
Sponsor Mindset Medical (industry)
Started 2024-07-16 → Primary completion 2024-08-22
Primary outcome
Respiratory Rate Accuracy
View full study on ClinicalTrials.gov

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

All 9
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K250078.
Vital Signs
K251200 · Oxehealth Limited · Feb 2026
Vital Signs
K243687 · Oxehealth Limited · Aug 2025
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
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · Faceheart Corp. · Sep 2023