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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Insertion System For A Cochlear Implant Electrode Array
510(k) Number K252339
Device Name iotaSOFT® Insertion System
Applicant
Iotamotion, Inc.
4205 White Bear Pkwy.
Suite 600
St. Paul,  MN  55110
Applicant Contact Khamporn Pendergrass
Correspondent
Darthur Consulting
5355 Pinehurst Park Dr.
#393
Charlotte,  NC  28211
Correspondent Contact Deborah Arthur
Regulation Number874.4450
Classification Product Code
QQH  
Date Received07/28/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT06106373
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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