# K240890: PanopticAI Vital Signs

- Pathway: 510(k) (Traditional)
- Applicant: PanopticAI technologies Limited
- Decided: Dec 23, 2024 after 266 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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 6.

## Most influential descendants
- K260066: PanopticAI Vital Signs (1.6.1-22) (2026), 0 descendants of its own

## Indications for use
The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera. The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects. The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring. The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.

Source page: https://510kreport.com/device/K240890
Methodology: https://510kreport.com/methodology