# K243539: Apollo TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Mag & More GmbH
- Decided: Aug 18, 2025 after 276 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222171: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+, Magstim Company, Ltd. (2023) Summary page 5.
- K232639: Apollo TMS Therapy System, Mag & More GmbH (2024) Summary page 5.

## Indications for use
The Apollo 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Source page: https://510kreport.com/device/K243539
Methodology: https://510kreport.com/methodology