Cleared Traditional

MEGA-TMS (K192823) - FDA 510(k) Clearance

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

K192823 · Soterix Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
681d
Days
Class 2
Risk

K192823 is an FDA 510(k) clearance for the MEGA-TMS. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Soterix Medical, Inc. (New York, US). The FDA issued a Cleared decision on August 13, 2021 after a review of 681 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Soterix Medical, Inc. devices

Submission Details

510(k) Number K192823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2019
Decision Date August 13, 2021
Days to Decision 681 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
533d slower than avg
Panel avg: 148d · This submission: 681d
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 20
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K192823.
Cadwell Guardian
K230415 · Cadwell Industries, Inc. · Aug 2023
SafeOp 2: Neural Informatix System
K213849 · Alphatec Spine, Inc. · Mar 2022
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K212166 · Inomed Medizintechnik GmbH · Jan 2022
Neuro-IOM system with Neuro-IOM.NET software
K190703 · Neurosoft , Ltd. · May 2021
NIM Vital, Nerve Integrity Monitor
K200759 · Medtronic Xomed, Inc. · Oct 2020
The EPAD 2 System
K182542 · Safeop Surgical, Inc. · Feb 2019