BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    iotaSOFT® Insertion System

    K Number: K252339 · Decision Jan 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    165

    Basic Information

    Device Name
    iotaSOFT® Insertion System
    K Number
    K252339
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iotamotion, Inc.
    Date Received
    July 28, 2025
    Decision Date
    January 9, 2026
    Product Code
    QQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QQH Powered Insertion System For A Cochlear Implant Electrode Array

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QQH), ordered by most recent decision date.

    iotaSOFT Insertion System - Drive Unit, Controller and Accessories

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Iotamotion, Inc.

    K Number Device Name
    DEN190055 iotaSOFT Insertion System - Drive Unit, Controller and Accessories