Cleared Traditional

SmartSpectra Vital Signs Monitor 1.0 (K254169) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K254169 · Presage Security, Inc. d/b/a Presage Technologies, Inc. · Cardiovascular device
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Jun 2026
Decision
177d
Days
Class 2
Risk

K254169 is an FDA 510(k) clearance for the SmartSpectra Vital Signs Monitor 1.0. Classified as Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (product code QME), Class II - Special Controls.

Submitted by Presage Security, Inc. d/b/a Presage Technologies, Inc. (Leesburg, US). The FDA issued a Cleared decision on June 18, 2026 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2785 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Presage Security, Inc. d/b/a Presage Technologies, Inc. devices

Submission Details

510(k) Number K254169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date June 18, 2026
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2785
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

All 11
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K254169.
PanopticAI Vital Signs (1.6.1-22)
K260066 · PanopticAI technologies Limited · May 2026
Vital Signs
K251200 · Oxehealth Limited · Feb 2026
Vital Signs
K243687 · Oxehealth Limited · Aug 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · Mindset Medical, Inc. · May 2025
PanopticAI Vital Signs
K240890 · PanopticAI technologies Limited · Dec 2024
Informed Vital Core Application (IVC App)
K241633 · Mindset Medical, Inc. · Nov 2024