Skip to content

iotaSOFT® Insertion System

by Iotamotion, Inc.

510(k) K252339

iotaSOFT Insertion System is a medical device (FDA Class II; FDA product code QQH, Powered Insertion System For A Cochlear Implant Electrode Array) made by Iotamotion, Inc., cleared under FDA 510(k) K252339 on 9 Jan 2026, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252339 Date9 Jan 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QQH
Device class
Class II
Regulation
21 CFR Part 874.4450
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Other devices from Iotamotion, Inc.

See all devices from Iotamotion, Inc. →