# K243319: Ampa One System (AMPA-001)

- Pathway: 510(k) (Traditional)
- Applicant: Neuromodulatory Devices & Applications
- Decided: Feb 13, 2025 after 113 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: 8 generations back to DEN070003 (2008). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 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 5.
- K220819: BrainsWay Deep TMS System, Brainsway, Ltd. (2022) Summary page 5.

## Most influential descendants
- K251210: Ampa One System (AMPA-001) (2025), 0 descendants of its own

## Indications for use
The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K243319
Methodology: https://510kreport.com/methodology