# K243459: Ultimate rTMS for OCD (M-series)

- Pathway: 510(k) (Traditional)
- Applicant: Brain Ultimate, Inc.
- Decided: Apr 17, 2025 after 160 days
- Product code: QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder)
- Device class: 2
- Regulation: 21 CFR 882.5802
- 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193006: MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system, Tonica Elektronik A/S (2020) Summary page 5.

## Indications for use
The Ultimate rTMS for OCD is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder(OCD).

Source page: https://510kreport.com/device/K243459
Methodology: https://510kreport.com/methodology