Cleared Traditional

K241633 - Informed Vital Core Application (IVC App) (FDA 510(k) Clearance)

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

K241633 · Mindset Medical, Inc. · Cardiovascular device
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Nov 2024
Decision
165d
Days
Class 2
Risk

K241633 is an FDA 510(k) clearance for the Informed Vital Core Application (IVC App). 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 November 18, 2024 after a review of 165 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 Mindset Medical, Inc. devices

Submission Details

510(k) Number K241633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 125d · This submission: 165d
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
NCT05853380 Completed Observational Industry-sponsored

A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

86
Patients (actual)
6
Sites
Condition studied Vital Sign Evaluation
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Dan Lubelski, MD
Sponsor Mindset Medical (industry)
Started 2023-06-02 → Primary completion 2023-06-29
Primary outcome
Pulse 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 K241633.
Vital Signs
K251200 · Oxehealth Limited · Feb 2026
Vital Signs
K243687 · Oxehealth Limited · Aug 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · Mindset Medical, Inc. · May 2025
PanopticAI Vital Signs
K240890 · PanopticAI technologies Limited · Dec 2024
FibriCheck
K232804 · Qompium NV · Jun 2024
FaceHeart Vitals Software Development Kit (FH vitals SDK)
K223622 · Faceheart Corp. · Sep 2023