# K251210: Ampa One System (AMPA-001)

- Pathway: 510(k) (Special)
- Applicant: Neuromodulatory Devices & Applications
- Decided: Jun 27, 2025 after 70 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243319: Ampa One System (AMPA-001), Neuromodulatory Devices & Applications (2025) Summary page 5.

## 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/K251210
Methodology: https://510kreport.com/methodology