# K251391: BrainsWay Deep TMS System

- Pathway: 510(k) (Traditional)
- Applicant: Brainsway, Ltd.
- Decided: Nov 7, 2025 after 186 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: 12 generations back to DEN070003 (2008). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.
- K231926: NeuroStar Advanced Therapy System (All previously cleared models), Neuronetics, Inc. (2024) Summary page 5.

## Indications for use
The BrainsWay Deep TMS TM 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. The BrainsWay Deep TMS TM System is also indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).

Source page: https://510kreport.com/device/K251391
Methodology: https://510kreport.com/methodology