# K231350: OCD MT Cap (85-00397-000)

- Pathway: 510(k) (Special)
- Applicant: Neuronetics
- Decided: Jun 8, 2023 after 30 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: 11 generations back to DEN070003 (2008). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar, Neuronetics, Inc. (2022) Summary page 4.
- K230029: NeuroStar Advanced Therapy System (Version 3.7), Neuronetics (2023) Summary page 4.

## Indications for use
The NeuroStar Advanced Therapy system 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/K231350
Methodology: https://510kreport.com/methodology