QQH · Class II · 21 CFR 874.4450

FDA Product Code QQH: Powered Insertion System For A Cochlear Implant Electrode Array

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.

Leading manufacturers include Iotamotion, Inc..

2
Total
1
Cleared
409d
Avg days
2021
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 165d recently vs 653d historically

FDA 510(k) Cleared Powered Insertion System For A Cochlear Implant Electrode Array Devices (Product Code QQH)

2 devices
1–2 of 2
Cleared Jan 09, 2026
iotaSOFT® Insertion System
K252339
Iotamotion, Inc.
Ear, Nose, Throat · 165d
Not Cleared Oct 01, 2021
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
DEN190055
Iotamotion, Inc.
Ear, Nose, Throat · 653d

About Product Code QQH - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QQH since 2021, with 1 receiving FDA clearance (average review time: 409 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under QQH have taken an average of 165 days to reach a decision - down from 653 days historically, suggesting improved FDA processing for this classification.

QQH devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →