Cleared Traditional

K182768 - TMS-Cobot TS MV (FDA 510(k) Clearance)

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

K182768 · Axilum Robotics · Neurology device
Feb 2019
Decision
142d
Days
Class 2
Risk

K182768 is an FDA 510(k) clearance for the TMS-Cobot TS MV. Classified as Electromechanical Arm For A Transcranial Magnetic Stimulation System (product code QFF), Class II - Special Controls.

Submitted by Axilum Robotics (Strasbourg, FR). The FDA issued a Cleared decision on February 17, 2019 after a review of 142 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date February 17, 2019
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 162d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5805
Definition To Provide Guidance For The Positioning And Orientation Of A Transcranial Magnetic Stimulation (tms) System Coil Under The Supervision Of A Tracking System.
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.