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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 / May 2026 / K260066

510(k) cleared

PanopticAI Vital Signs (1.6.1-22)

PanopticAI Technologies Limited · May 21, 2026 · K260066

FDA cleared the PanopticAI Vital Signs (1.6.1-22) from PanopticAI Technologies Limited on May 21, 2026 under K260066, 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 Jan 9, 2026. The decision came 132 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 PanopticAI Technologies Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260066?

K260066 is the FDA 510(k) for PanopticAI Vital Signs (1.6.1-22), submitted by PanopticAI Technologies Limited. FDA's decision date was May 21, 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 PanopticAI Vital Signs (1.6.1-22)?

PanopticAI Technologies Limited, based in Hong Kong, is the applicant of record for K260066.

How long did the K260066 review take?

FDA received the submission on Jan 9, 2026 and issued its decision on May 21, 2026, 132 days later.

← All decisions in May 2026

Sources