# K231926: NeuroStar Advanced Therapy System (All previously cleared models)

- Pathway: 510(k) (Traditional)
- Applicant: Neuronetics, Inc.
- Decided: Mar 22, 2024 after 266 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 1 (0 Class I)
- 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.
7 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230029: NeuroStar Advanced Therapy System (Version 3.7), Neuronetics (2023) Summary page 5.

## Most influential descendants
- K243700: Apollo TMS Therapy System (2025), 1 descendant of its own
- K251125: MagVenture TMS Therapy System (2025), 1 descendant of its own
- 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) (2025), 1 descendant of its own
- K260691: BTL-699 (2026), 0 descendants of its own
- K260560: Apollo TMS Therapy System;Apollo light TMS Therapy System (2026), 0 descendants of its own

## Recalls of this device
- Aug 24, 2026 · Class II · Z-0142-2027: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

## Indications for use
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K231926
Methodology: https://510kreport.com/methodology