Cleared Traditional

K234080 - MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234080 · Soterix Medical, Inc. · Neurology device
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Mar 2024
Decision
94d
Days
Class 2
Risk

K234080 is an FDA 510(k) clearance for the MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S). Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Soterix Medical, Inc. (Woodbridge, US). The FDA issued a Cleared decision on March 25, 2024 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Soterix Medical, Inc. devices

Submission Details

510(k) Number K234080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date March 25, 2024
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 148d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 138
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K234080.
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