# K251119: MagVenture TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Tonica Elektronik A/S
- Decided: Aug 8, 2025 after 119 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: 11 generations back to DEN070003 (2008). 24 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230029: NeuroStar Advanced Therapy System (Version 3.7), Neuronetics (2023) Summary page 5.

## Most influential descendants
- K260691: BTL-699 (2026), 0 descendants of its own
- K260402: MeRT System (2026), 0 descendants of its own
- K260189: MagVenture Accelerated TMS (aTMS) Therapy System (2026), 0 descendants of its own

## Indications for use
MagVenture TMS Therapy 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 have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. The MagVenture TMS Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Source page: https://510kreport.com/device/K251119
Methodology: https://510kreport.com/methodology