Cleared Special

K252032 - T65 (9016E061-) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252032 · Tonica Elektronik A/S · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
30d
Days
Class 2
Risk

K252032 is an FDA 510(k) clearance for the T65 (9016E061-). Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on July 30, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tonica Elektronik A/S devices

Submission Details

510(k) Number K252032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date July 30, 2025
Days to Decision 30 days
Submission Type Special
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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

MagVenture A/S
Freja Lüthje

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K252032.
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · Nexstim Oyj · Mar 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
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SPRY TMS Therapy System (0550)
K251653 · Soterix Medical, Inc. · Feb 2026
BrainsWay Deep TMS System
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CloudTMS Edge
K250689 · Teleemg, LLC · Sep 2025
BrainsWay Deep TMS System
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