Cleared Traditional

MagVenture TMS Atlas Neuro Navigation System (K221544) - FDA 510(k) Clearance

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

K221544 · Tonica Elektronik A/S · Neurology device
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Mar 2023
Decision
294d
Days
Class 2
Risk

K221544 is an FDA 510(k) clearance for the MagVenture TMS Atlas Neuro Navigation System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on March 17, 2023 after a review of 294 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Tonica Elektronik A/S devices

Submission Details

510(k) Number K221544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2022
Decision Date March 17, 2023
Days to Decision 294 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
146d slower than avg
Panel avg: 148d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 159
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K221544.
Sinobot X1
K220072 · Sinovation (Beijing) Medical Technology Co., Ltd. · Jun 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
K223552 · Brainlab AG · Apr 2023
Localite TMS Navigator TS
K223577 · Localite GmbH · Apr 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
K230201 · PAJUNK GmbH Medizintechnologie · Feb 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
K212194 · Stryker Corporation · Feb 2023
ClearPoint System
K222519 · ClearPoint Neuro, Inc. · Sep 2022