# K251449: BrainsWay Deep TMS System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Sep 13, 2025 after 127 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: 10 generations back to DEN070003 (2008). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222196: Deep TMS System, Brainsway, Ltd. (2024) Summary page 5.
- K220177: Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K, Magnus Medical, Inc. (2022) Summary page 5.

## Indications for use
The BrainsWay Deep TMSTM 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/K251449
Methodology: https://510kreport.com/methodology