510(k) · Cleared
ClearedSmartSpectra Vital Signs Monitor 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Presage Security, Inc. d/b/a Presage Technologies, Inc. · QME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cleared on Jun 18, 2026 as substantially equivalent to K211906 (Oxehealth Limited, 2021) after a 177-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Jun 18, 2026
- Review
- 177 days
- Class
- Class II
- Product code
- QME
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200019 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QME? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QME device
- #1 K211906 Vital Signsscore 28.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211906 | Vital SignsSummary page 5…-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate Regulation Number: 870.2785 Product Code(s): QME Legally Marketed Predicate Device K211906 Oxehealth Vital Signs Device Description Summary The SmartSpectra device is a software development kit (“SDK”) which uses s… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K211906.
How does its category compare?
All QME devicesQME Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QME
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QME
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QME
No recall names QME since 2007.
Adverse event reports per year · QME
No MAUDE report names QME since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 266 | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 4 | 190 | 0 | — |
What is it indicated for?
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…
Read the full statement (153 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254169: SmartSpectra Vital Signs Monitor 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254169
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026