# Neuronetics, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 15 (2008–2024): 14 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Neuronetics, Inc. (8); Neuronetics (7)
- Product codes: OBP (13), QCI (2)
- 510(k) review time since 2016: median 88 days, against 119 for FDA's reviews in the same codes and years (5 of 9 faster)
- Predicates its devices cite: 55 (53 its own); citations of its devices by later devices: 70 (53 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainsway, Ltd.: 1 (https://510kreport.com/company/brainsway)
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)

## Firms that cite its devices most
- Tonica Elektronik A/S: 5 (https://510kreport.com/company/tonica-elektronik-a-s)
- The Magstim Company, Ltd.: 5 (https://510kreport.com/company/magstim)
- Brainsway, Ltd.: 3 (https://510kreport.com/company/brainsway)
- Mag & More GmbH: 3 (https://510kreport.com/company/mag-more)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)

## Its most-cited devices
- K133408: Neurostar TMS Therapy System (2014), cited by 9
- K083538: Neurostar TMS Therapy System, Model 1.1 (2008), cited by 9
- K160703: NeuroStar TMS Therapy System (2016), cited by 8
- K161519: NeuroStar TMS Therapy System (2016), cited by 7
- DEN070003: Neurostar TMS System (2008), cited by 6
- K130233: Neurostar TMS Therapy System (2013), cited by 6

## Recent decisions
- K231926: NeuroStar Advanced Therapy System (All previously cleared models) (Mar 22, 2024)
- K233621: NeuroStar Advanced Therapy System (Version 3.8) (Dec 13, 2023)
- K231350: OCD MT Cap (85-00397-000) (Jun 8, 2023)
- K230029: NeuroStar Advanced Therapy System (Version 3.7) (Apr 4, 2023)
- K222230: NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health (Aug 24, 2022)
- K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (Jul 15, 2022)
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (May 6, 2022)
- K213543: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health (Dec 10, 2021)

Source page: https://510kreport.com/company/neuronetics