Cleared Traditional

iotaSOFT? Insertion System

K252339 · Iotamotion, Inc. · Ear, Nose, Throat
Jan 2026
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K252339 is an FDA 510(k) clearance for the iotaSOFT? Insertion System, a Powered Insertion System For A Cochlear Implant Electrode Array (Class II — Special Controls, product code QQH), submitted by Iotamotion, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 9, 2026, 165 days after receiving the submission on July 28, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4450.

Submission Details

510(k) Number K252339 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2025
Decision Date January 09, 2026
Days to Decision 165 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code QQH — Powered Insertion System For A Cochlear Implant Electrode Array
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4450
Definition A Powered Insertion System For A Cochlear Implant Electrode Array Is A Prescription Device Used To Assist In Placing An Electrode Array Into The Cochlea.