# K210201: Deep Transcranial Magnetic Stimulation (DTMS) System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Aug 17, 2021 after 204 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070003 (2008). 4 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122288: Brainsway Deep TMS System, Brainsway, Ltd. (2013) Summary page 4.
- K173540: Brainsway Deep (DTMS) System, Brainsway, Ltd. (2018) Summary page 4.

## Most influential descendants
- K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (2022), 16 descendants of its own
- K230029: NeuroStar Advanced Therapy System (Version 3.7) (2023), 13 descendants of its own
- K231926: NeuroStar Advanced Therapy System (All previously cleared models) (2024), 7 descendants of its own
- K251119: MagVenture TMS Therapy System (2025), 3 descendants of its own
- K222196: Deep TMS System (2024), 2 descendants of its own

## Indications for use
The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Source page: https://510kreport.com/device/K210201
Methodology: https://510kreport.com/methodology