SmartSpectra Vital Signs Monitor 1.0— 510(k) K254169
Substantially EquivalentPresage Security, Inc. d/b/a Presage Technologies, Inc.
FDA 510(k) clearance K254169 for SmartSpectra Vital Signs Monitor 1.0, Substantially Equivalent on 2026-06-18. Applicant: Presage Security, Inc. d/b/a Presage Technologies, Inc.. Device class: 2.
Summary
SmartSpectra Vital Signs Monitor 1.0 is from Presage Security, doing business as Presage Technologies. It's filed under QME, software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate, and the record doesn't say which of those this product measures.
Class II, 21 CFR 870.2785. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Presage filed from Leesburg, Virginia. The decision came 177 calendar days after receipt (December 23, 2025 to June 18, 2026).
Clearance details
- Applicant
- Presage Security, Inc. d/b/a Presage Technologies, Inc.
- Product code
- Product code QME
- Device class
- Class 2
- Regulation
- 21 CFR 870.2785
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leesburg, VA, US
Recent devices under product code QME
view allData sourced from openFDA. This site is unofficial and independent of the FDA.