Not Cleared Direct

DEN190055 - iotaSOFT Insertion System - Drive Unit, Controller and Accessories (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190055 · Iotamotion, Inc. · Ear, Nose, Throat device
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Oct 2021
Decision
653d
Days
Class 2
Risk

DEN190055 is an FDA 510(k) submission (not cleared) for the iotaSOFT Insertion System - Drive Unit, Controller and Accessories. Classified as Powered Insertion System For A Cochlear Implant Electrode Array (product code QQH), Class II - Special Controls.

Submitted by Iotamotion, Inc. (Iowa City, US). The FDA issued a Not Cleared (DENG) decision on October 1, 2021 after a review of 653 days.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4450 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 653 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Iotamotion, Inc. devices

Submission Details

510(k) Number DEN190055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 18, 2019
Decision Date October 01, 2021
Days to Decision 653 days
Submission Type Direct
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
564d slower than avg
Panel avg: 89d · This submission: 653d
Pathway characteristics

Device Classification

Product Code QQH Powered Insertion System For A Cochlear Implant Electrode Array
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.