# K182853: HORIZON TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Magstim Company, Ltd.
- Decided: Mar 15, 2019 after 156 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN070003 (2008). 17 ancestors in all.
10 later devices descend from it; 2 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)
- K173620: Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S (2018) Summary page 4.
- K180907: HORIZON TMS Therapy System, Magstim Company, Ltd. (2018) Summary page 4.

## Most influential descendants
- K211389: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation (2021), 6 descendants of its own
- K222171: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ (2023), 4 descendants of its own
- K232639: Apollo TMS Therapy System (2024), 3 descendants of its own
- K232235: Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro (2023), 2 descendants of its own
- K243700: Apollo TMS Therapy System (2025), 1 descendant of its own

## Recalls of this device
- Mar 23, 2020 · Class II · Z-1965-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
- Mar 23, 2020 · Class II · Z-1966-2020: It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.

## Indications for use
The HORIZON TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K182853
Methodology: https://510kreport.com/methodology