Cleared Traditional

K252339 - iotaSOFT® Insertion System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K252339 · Iotamotion, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
165d
Days
Class 2
Risk

K252339 is an FDA 510(k) clearance for the iotaSOFT® Insertion System. Classified as Powered Insertion System For A Cochlear Implant Electrode Array (product code QQH), Class II - Special Controls.

Submitted by Iotamotion, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 9, 2026 after a review of 165 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Iotamotion, Inc. devices

Submission Details

510(k) Number K252339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2025
Decision Date January 09, 2026
Days to Decision 165 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 89d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Darthur Consulting
Deborah Arthur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT06106373 Completed Interventional Industry-sponsored

iotaSOFT Pediatric Study

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

20
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Loss, Unilateral
Study design Single group
Eligibility All sexes · 9 Months+ · Healthy volunteers accepted
Principal investigator Laura Chenier
Sponsor iotaMotion, Inc. (industry)
Started 2022-05-17 → Primary completion 2024-10-24 → Completed 2025-07-10
Primary outcome
Safety related to adverse events
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov