OBP · Class II · 21 CFR 882.5805

FDA Product Code OBP: Transcranial Magnetic Stimulator

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.

Leading manufacturers include Brainsway , Ltd., Magstim Company, Ltd. and Neuronetics, Inc..

66
Total
65
Cleared
156d
Avg days
2008
Since
Stable submission activity - 18 submissions in the last 2 years
Consistent review times: 153d avg (recent)

FDA 510(k) Cleared Transcranial Magnetic Stimulator Devices (Product Code OBP)

66 devices
1–24 of 66
Cleared May 22, 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189
Tonica Elektronik A/S
Neurology · 120d
Cleared May 22, 2026
Apollo TMS Therapy System
K260560
Mag & More GmbH
Neurology · 92d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358
Nexstim Oyj
Neurology · 234d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098
Nexstim Oyj
Neurology · 178d
Cleared Feb 20, 2026
SPRY TMS Therapy System (0550)
K251653
Soterix Medical, Inc.
Neurology · 267d
Cleared Nov 07, 2025
BrainsWay Deep TMS System
K251391
Brainsway , Ltd.
Neurology · 186d
Cleared Sep 14, 2025
CloudTMS Edge
K250689
Teleemg, LLC
Neurology · 192d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449
Brainsway , Ltd.
Neurology · 127d
Cleared Sep 04, 2025
Apollo TMS Therapy System
K243700
Mag & More GmbH
Neurology · 279d
Cleared Aug 18, 2025
Apollo TMS Therapy System
K243539
Mag & More GmbH
Neurology · 276d
Cleared Aug 11, 2025
MagVenture TMS Therapy System
K251125
Tonica Elektronik A/S
Neurology · 122d
Cleared Aug 08, 2025
MagVenture TMS Therapy System
K251119
Tonica Elektronik A/S
Neurology · 119d
Cleared Jul 30, 2025
T65 (9016E061-)
K252032
Tonica Elektronik A/S
Neurology · 30d
Cleared Jun 27, 2025
Ampa One System (AMPA-001)
K251210
Neuromodulatory Devices & Applications
Neurology · 70d
Cleared Apr 17, 2025
Ultimate rTMS
K243460
Brain Ultimate, Inc.
Neurology · 160d
Cleared Mar 17, 2025
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K243869
The Magstim Company Limited
Neurology · 90d
Cleared Feb 13, 2025
Ampa One System (AMPA-001)
K243319
Neuromodulatory Devices & Applications
Neurology · 113d
Cleared Aug 30, 2024
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K241518
The Magstim Company Limited
Neurology · 93d
Cleared May 31, 2024
Deep TMS System
K222196
Brainsway , Ltd.
Neurology · 679d
Cleared May 24, 2024
Apollo TMS Therapy System
K232639
Mag & More GmbH
Neurology · 268d
Cleared Mar 22, 2024
NeuroStar Advanced Therapy System (All previously cleared models)
K231926
Neuronetics, Inc.
Neurology · 266d
Cleared Feb 09, 2024
ZapStim Controller Application (Z1023)
K233631
Revital Lab, Inc.
Neurology · 88d
Cleared Dec 29, 2023
NQ TMS for MDD (NQv1-MU-01)
K232688
Neuroqore, Inc.
Neurology · 119d
Cleared Dec 13, 2023
NeuroStar Advanced Therapy System (Version 3.8)
K233621
Neuronetics
Neurology · 30d

About Product Code OBP - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code OBP since 2008, with 65 receiving FDA clearance (average review time: 156 days).

Submission volume has remained relatively stable over the observed period, with 18 submissions in the last 24 months.

FDA 510(k) Review Time - OBP Product Code

FDA review times for OBP submissions have been consistent, averaging 153 days recently vs 158 days historically.

OBP devices are reviewed by the Neurology panel. Browse all Neurology devices →