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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K254169

510(k) cleared

SmartSpectra Vital Signs Monitor 1.0

Presage Security, Inc. d/b/a Presage Technologies, Inc. · Jun 18, 2026 · K254169

FDA cleared the SmartSpectra Vital Signs Monitor 1.0 from Presage Security, Inc. d/b/a Presage Technologies, Inc. on Jun 18, 2026 under K254169, a traditional 510(k). The device falls under product code QME, Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate, regulated at 21 CFR 870.2785 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 23, 2025. The decision came 177 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Presage Security, Inc. d/b/a Presage Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254169?

K254169 is the FDA 510(k) for SmartSpectra Vital Signs Monitor 1.0, submitted by Presage Security, Inc. d/b/a Presage Technologies, Inc.. FDA's decision date was Jun 18, 2026, under product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate).

Who makes the SmartSpectra Vital Signs Monitor 1.0?

Presage Security, Inc. d/b/a Presage Technologies, Inc., based in Leesburg, VA, is the applicant of record for K254169.

How long did the K254169 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Jun 18, 2026, 177 days later.

← All decisions in June 2026

Sources