# K254169: SmartSpectra Vital Signs Monitor 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Presage Security, Inc. d/b/a Presage Technologies, Inc.
- Decided: Jun 18, 2026 after 177 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 Presage SmartSpectra Vital Signs Monitor is intended for non-invasive spot measurement of pulse rate and respiratory rate in healthy individuals during routine interactions with healthcare professionals such as during routine checkups. It is software assessing video footage from a fixed-installation solution (smartphone mounted in a static-mount) in admissions and examination areas of hospitals, clinics, general care, or other secured environments, where a single human face can be maintained in view, with professional healthcare oversight. The SmartSpectra system is intended for use by trained healthcare professionals and should not be used by untrained users. The SmartSpectra Vital Signs Monitor is intended for use on humans 18 to 70 years old who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject or for use on patients that have been admitted to hospitals or in ICUs.

Source page: https://510kreport.com/device/K254169
Methodology: https://510kreport.com/methodology