Is SmartSpectra Vital Signs Monitor 1.0 FDA cleared?

FDA's records list K254169 for SmartSpectra Vital Signs Monitor 1.0 from Presage Security, Inc. d/b/a Presage Technologies, Inc.: 510(k), decision date Jun 18, 2026, decision "Substantially Equivalent". The 510(k) pathway means the device was cleared, not approved.

FDA 510(k) · Presage

K254169: SmartSpectra Vital Signs Monitor 1.0 (Presage Security, Inc. d/b/a Presage Technologies, Inc.)

Presage Security, Inc. d/b/a Presage Technologies, Inc. received FDA 510(k) K254169 for SmartSpectra Vital Signs Monitor 1.0, with a decision date of Jun 18, 2026 (substantially equivalent).

Prescription or OTC: Unknown (no FDA document we parsed states it).

FDA record for K254169 FDA summary or statement (PDF)

FDA facts

Official fields for K254169
FDA number	K254169
Pathway	510(k)
Applicant	Presage Security, Inc. d/b/a Presage Technologies, Inc.
Device name	SmartSpectra Vital Signs Monitor 1.0
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	Dec 23, 2025
Decision date	Jun 18, 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 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.

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.