# K220177: Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K

- Pathway: 510(k) (Traditional)
- Applicant: Magnus Medical, Inc.
- Decided: Sep 1, 2022 after 223 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). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182700: Nexstim Navigated Brain Therapy (NBT) System 2, Nexstim Plc (2019) Summary page 4.

## Most influential descendants
- K260189: MagVenture Accelerated TMS (aTMS) Therapy System (2026), 0 descendants of its own
- K251449: BrainsWay Deep TMS System (2025), 0 descendants of its own

## Indications for use
The Magnus Neuromodulation System with SAINT Technology is indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Source page: https://510kreport.com/device/K220177
Methodology: https://510kreport.com/methodology