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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 / March 2026 / K252923

510(k) cleared

IASIS i2 Relaxation Neurofeedback System

Iasis Technologies · Mar 13, 2026 · K252923

FDA cleared the IASIS i2 Relaxation Neurofeedback System from Iasis Technologies on Mar 13, 2026 under K252923, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Sep 15, 2025. The decision came 179 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 Iasis Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252923?

K252923 is the FDA 510(k) for IASIS i2 Relaxation Neurofeedback System, submitted by Iasis Technologies. FDA's decision date was Mar 13, 2026.

Who makes the IASIS i2 Relaxation Neurofeedback System?

Iasis Technologies, based in Murrieta, CA, is the applicant of record for K252923.

How long did the K252923 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Mar 13, 2026, 179 days later.

← All decisions in March 2026