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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 / January 2026 / K252339

510(k) cleared

iotaSOFT® Insertion System

Iotamotion, Inc. · Jan 9, 2026 · K252339

FDA cleared the iotaSOFT® Insertion System from Iotamotion, Inc. on Jan 9, 2026 under K252339, a traditional 510(k). The device falls under product code QQH, Powered Insertion System For A Cochlear Implant Electrode Array, regulated at 21 CFR 874.4450 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jul 28, 2025. The decision came 165 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 Iotamotion, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252339?

K252339 is the FDA 510(k) for iotaSOFT® Insertion System, submitted by Iotamotion, Inc.. FDA's decision date was Jan 9, 2026, under product code QQH (Powered Insertion System For A Cochlear Implant Electrode Array).

Who makes the iotaSOFT® Insertion System?

Iotamotion, Inc., based in St. Paul, MN, is the applicant of record for K252339.

How long did the K252339 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Jan 9, 2026, 165 days later.

← All decisions in January 2026