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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
510(k) Number K254169
Device Name SmartSpectra Vital Signs Monitor 1.0
Applicant
Presage Security, Inc. d/b/a Presage Technologies, Inc.
50 Catoctin Cir. NE #101
Office 114
Leesburg,  VA  20176
Applicant Contact Michael Kenney
Correspondent
Presage Security, Inc. d/b/a Presage Technologies, Inc.
50 Catoctin Cir. NE #101
Office 114
Leesburg,  VA  20176
Correspondent Contact Michael Kenney
Regulation Number870.2785
Classification Product Code
QME  
Date Received12/23/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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