# K243700: Apollo TMS Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Mag & More GmbH
- Decided: Sep 4, 2025 after 279 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). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 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.
- K180313: Apollo TMS Therapy System, Mag & More GmbH (2018) Summary page 5.
- K232639: Apollo TMS Therapy System, Mag & More GmbH (2024) Summary page 5.

## Most influential descendants
- K260560: Apollo TMS Therapy System;Apollo light TMS Therapy System (2026), 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 and as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K243700
Methodology: https://510kreport.com/methodology