# K252339: iotaSOFT® Insertion System

- Pathway: 510(k) (Traditional)
- Applicant: Iotamotion, Inc.
- Decided: Jan 9, 2026 after 165 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
Longest line of descent: 1 generation back to DEN190055 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190055: iotaSOFT Insertion System - Drive Unit, Controller and Accessories, Iotamotion, Inc. (2021) Summary page 5.

## 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 array insertion. The iotaSOFT Insertion System is indicated for use in cochlear implant patients ages 4 years and older during cochlear implant procedures using either a round window or cochleostomy approach.

Source page: https://510kreport.com/device/K252339
Methodology: https://510kreport.com/methodology