# DEN190055: iotaSOFT Insertion System - Drive Unit, Controller and Accessories

- Pathway: De Novo (Direct)
- Applicant: Iotamotion, Inc.
- Decided: Oct 1, 2021 after 653 days
- Product code: QQH (Powered Insertion System For A Cochlear Implant Electrode Array)
- Device class: 2
- Regulation: 21 CFR 874.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252339: iotaSOFT® Insertion System (2026), 0 descendants of its own

## Indications for use
The iotaSOFT™ Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion. The iotaSOFT Insertion System is intended for use in cochlear implant patients ages 12 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

Source page: https://510kreport.com/device/DEN190055
Methodology: https://510kreport.com/methodology