FDA 510(k) · Mindset Medical
K250078: Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (Mindset Medical, Inc.)
Mindset Medical, Inc. received FDA 510(k) K250078 for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0), with a decision date of May 30, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K250078 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mindset Medical, Inc. |
| Device name | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) |
| Product code | QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| Regulation (21 CFR) | 870.2785 |
| Device class | Class 2 |
| Date received | Jan 13, 2025 |
| Decision date | May 30, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K211906 Vital Signs (Oxehealth)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QME is "Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate", class 2, 21 CFR 870.2785. FDA's 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."
Our labels for filtering: claim Heart rate / pulse, sensor Camera (rPPG). These are heuristics, not FDA fields.