Cleared Traditional

K234080 - MEGA-IOM system with Neuro-IOM.NET soft...

K234080 is an FDA 510(k) clearance for MEGA-IOM system with Neuro-IOM.NET soft..., manufactured by Soterix Medical, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K234080

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.

GWF Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K234080.
Natus Ultrapro S100 (982A0594)
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ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
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Cadwell Guardian
K230415 · Cadwell Industries, Inc. · Aug 2023
SafeOp 2: Neural Informatix System
K213849 · Alphatec Spine, Inc. · Mar 2022