510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252339Substantially Equivalent

iotaSOFT® Insertion System

Iotamotion Inc, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252339 is the FDA 510(k) clearance record for iotaSOFT® Insertion System, a class II device, cleared for Iotamotion, Inc. on under FDA product code QQH (Powered Insertion System For A Cochlear Implant Electrode Array). FDA's definition for product code QQH reads: "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". FDA records list 2 510(k) clearances for Iotamotion, Inc., from to . As of , FDA records show no recalls naming K252339.

Clearance record

Decision date
Received
(165 days to decision)
Product code
QQH Powered Insertion System For A Cochlear Implant Electrode Array
Regulation
21 CFR 874.4450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Iotamotion, Inc. 4205 White Bear Pkwy., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQH

Trailing 12 months
1 clearance under product code QQH in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260