Cleared Traditional

K160309 - Neurosoft TMS (FDA 510(k) Clearance)

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

K160309 · Teleemg, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
322d
Days
Class 2
Risk

K160309 is an FDA 510(k) clearance for the Neurosoft TMS. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Teleemg, LLC (Woburn, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Teleemg, LLC devices

Submission Details

510(k) Number K160309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2016
Decision Date December 22, 2016
Days to Decision 322 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 148d · This submission: 322d
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 63
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K160309.
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · Nexstim Oyj · Mar 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · Nexstim Oyj · Mar 2026
SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026
BrainsWay Deep TMS System
K251391 · Brainsway , Ltd. · Nov 2025
CloudTMS Edge
K250689 · Teleemg, LLC · Sep 2025
BrainsWay Deep TMS System
K251449 · Brainsway , Ltd. · Sep 2025