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510(k) K254169

SmartSpectra Vital Signs Monitor 1.0 by Presage Security, Inc. d/b/a Presage Technologies, Inc. — Product Code QME

K254169 is an FDA 510(k) premarket notification submitted by Presage Security, Inc. d/b/a Presage Technologies, Inc. for the device "SmartSpectra Vital Signs Monitor 1.0". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate), a Class II device regulated under 21 CFR 870.2785.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
December 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Device Class
Class II
Regulation Number
870.2785
Review Panel
CV
Submission Type

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.

Other clearances for product code QME

  • K253650 — Anura Mobile Core SDK (M1) (June 11, 2026)
  • K260066 — PanopticAI Vital Signs (1.6.1-22) (May 21, 2026)
  • K251200 — Vital Signs (February 2, 2026)
  • K243687 — Vital Signs (August 27, 2025)
  • K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) (May 30, 2025)
  • K240890 — PanopticAI Vital Signs (December 23, 2024)
  • K241633 — Informed Vital Core Application (IVC App) (November 18, 2024)
  • K232804 — FibriCheck (June 7, 2024)
  • K223622 — FaceHeart Vitals Software Development Kit (FH vitals SDK) (September 1, 2023)
  • K220899 — Oxehealth Vital Signs (April 29, 2022)

FDA data resources