FDA 510(k) · PanopticAI
K260066: PanopticAI Vital Signs (1.6.1-22) (PanopticAI Technologies Limited)
PanopticAI Technologies Limited received FDA 510(k) K260066 for PanopticAI Vital Signs (1.6.1-22), with a decision date of May 21, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K260066 |
|---|---|
| Pathway | 510(k) |
| Applicant | PanopticAI Technologies Limited |
| Device name | PanopticAI Vital Signs (1.6.1-22) |
| 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 9, 2026 |
| Decision date | May 21, 2026 |
| 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 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.
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.
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.