Cleared Traditional

K182700 - Nexstim Navigated Brain Therapy (NBT) S...

K182700 is the FDA 510(k) clearance for Nexstim Navigated Brain Therapy (NBT) S... by Nexstim Plc. It is a Class 2 Neurology device (product code OBP) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K182700 · Nexstim Plc · Neurology device
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Mar 2019
Decision
176d
Days
Class 2
Risk

K182700 is an FDA 510(k) clearance for the Nexstim Navigated Brain Therapy (NBT) System 2. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Nexstim Plc (Helsinki, FI). The FDA issued a Cleared decision on March 22, 2019 after a review of 176 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - 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 Nexstim Plc devices

Submission Details

510(k) Number K182700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date March 22, 2019
Days to Decision 176 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
28d slower than avg
Panel avg: 148d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
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 - OBP Transcranial Magnetic Stimulator

All 47
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K182700.
Brainsway Deep TMS System
K203735 · Brainsway , Ltd. · Apr 2021
NeuroStar Advanced Therapy
K201158 · Neuronetics, Inc. · Nov 2020
HORIZON TMS Therapy System with Navigation
K183376 · Magstim Company, Ltd. · Apr 2019
HORIZON TMS Therapy System
K182853 · Magstim Company, Ltd. · Mar 2019
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620 · Tonica Elektronik A/S · Aug 2018
HORIZON TMS Therapy System
K180907 · Magstim Company, Ltd. · Aug 2018