# K250078: Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Mindset Medical, Inc.
- Decided: May 30, 2025 after 137 days
- Product code: QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate)
- Device class: 2
- Regulation: 21 CFR 870.2785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200019 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211906: Vital Signs, Oxehealth Limited (2021) Summary page 5.

## Indications for use
The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse and respiration rate of adult patients in home use, hospitals, clinics, and long-term care settings. The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring. Informed Vital Core is not intended to independently direct therapy.

Source page: https://510kreport.com/device/K250078
Methodology: https://510kreport.com/methodology