# K260066: PanopticAI Vital Signs (1.6.1-22)

- Pathway: 510(k) (Traditional)
- Applicant: PanopticAI Technologies Limited
- Decided: May 21, 2026 after 132 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: 3 generations back to DEN200019 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240890: PanopticAI Vital Signs, PanopticAI technologies Limited (2024) Summary page 7.
- K211906: Vital Signs, Oxehealth Limited (2021) Summary page 7.

## Indications for use
The PanopticAI Vital Signs device is intended for non-invasive spot measurement of pulse rate and respiratory rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera. The PanopticAI Vital Signs device is intended for use by healthcare professionals. The PanopticAI Vital Signs device is indicated for use on adults 18 to 60 years old who do not require critical care or continuous vital signs monitoring. The PanopticAI Vital Signs device is not intended for continuous monitoring, apnea detection, or to independently direct therapy. It is not intended to be the sole method to assess a subject's physical health condition. The pulse rate and respiratory rate measurements it provides should complement, not replace, professional medical care and/or prescribed therapy.

Source page: https://510kreport.com/device/K260066
Methodology: https://510kreport.com/methodology