# K243869: Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company Limited
- Decided: Mar 17, 2025 after 90 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.

## Most influential descendants
- K252358: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) (2026), 0 descendants of its own

## Indications for use
For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K243869
Methodology: https://510kreport.com/methodology