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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 / K253650

510(k) cleared

Anura Mobile Core SDK (M1)

Nuralogix Corporation · Jun 11, 2026 · K253650

FDA cleared the Anura Mobile Core SDK (M1) from Nuralogix Corporation on Jun 11, 2026 under K253650, 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 Nov 20, 2025. The decision came 203 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 Nuralogix Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253650?

K253650 is the FDA 510(k) for Anura Mobile Core SDK (M1), submitted by Nuralogix Corporation. FDA's decision date was Jun 11, 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 Anura Mobile Core SDK (M1)?

Nuralogix Corporation, based in Toronto, is the applicant of record for K253650.

How long did the K253650 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Jun 11, 2026, 203 days later.

← All decisions in June 2026