# K252358: Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

- Pathway: 510(k) (Traditional)
- Applicant: Nexstim Oyj
- Decided: Mar 20, 2026 after 234 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: 13 generations back to DEN070003 (2008). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243869: Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0), The Magstim Company Limited (2025) Summary page 5.

## Indications for use
NBS 6 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. For Adolescents: NBS 6 is indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K252358
Methodology: https://510kreport.com/methodology