# K251125: MagVenture TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Tonica Elektronik A/S
- Decided: Aug 11, 2025 after 122 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). 25 ancestors in all.
1 later device descends from it; 1 cites 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)
- K231926: NeuroStar Advanced Therapy System (All previously cleared models), Neuronetics, Inc. (2024) Summary page 5.
- K150641: MagVita TMS Therapy System, Tonica Elektronik A/S (2015) Summary page 6.
- K170114: MagVita TMS Therapy - w/MagPro R20, Tonica Elektronik A/S (2017) Summary page 6.
- K171481: MagVita TMS Therapy System, Tonica Elektronik A/S (2017) Summary page 6.
- K171967: MagVita TMS Therapy System, Tonica Elektronik A/S (2017) Summary page 6.
- K172667: MagVita TMS Therapy w/MagPro R20, Tonica Elektronik A/S (2017) Summary page 6.
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 6.

## Most influential descendants
- K260691: BTL-699 (2026), 0 descendants of its own

## Indications for use
MagVenture TMS Therapy System is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K251125
Methodology: https://510kreport.com/methodology