# K232639: Apollo TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Mag & More GmbH
- Decided: May 24, 2024 after 268 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: 9 generations back to DEN070003 (2008). 20 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182853: HORIZON TMS Therapy System, Magstim Company, Ltd. (2019) Summary page 4.
- K180313: Apollo TMS Therapy System, Mag & More GmbH (2018) Summary page 4.

## Most influential descendants
- K243700: Apollo TMS Therapy System (2025), 1 descendant of its own
- K260560: Apollo TMS Therapy System;Apollo light TMS Therapy System (2026), 0 descendants of its own
- K243539: Apollo TMS Therapy System (2025), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K232639
Methodology: https://510kreport.com/methodology