# Soterix Medical, Inc.

- Location (FDA's records): Woodbridge, NJ
- FDA decisions: 6 (2017–2026): 6 510(k) clearances
- Product codes: GWF (2), PCC (1), HAW (1), EGJ (1), OBP (1)
- 510(k) review time since 2016: median 231 days, against 134 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cefaly Technology: 1 (https://510kreport.com/company/cefaly-technology)
- Nexstim OY: 1 (https://510kreport.com/company/nexstim)
- Magstim Company Us, LLC: 1 (https://510kreport.com/company/magstim-company-us)
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)
- Dynatronics Corp.: 1 (https://510kreport.com/company/dynatronics)
- Neurosoft, Inc.: 1 (https://510kreport.com/company/neurosoft)
- Remed Co., Ltd.: 1 (https://510kreport.com/company/remed)

## Firms that cite its devices most
- Eemagine Medical Imaging Solutions GmbH: 1 (https://510kreport.com/company/eemagine-medical-imaging-solutions)
- Tonica Elektronik A/S: 1 (https://510kreport.com/company/tonica-elektronik-a-s)
- Localite GmbH: 1 (https://510kreport.com/company/localite)
- Torax Medical, Inc.: 1 (https://510kreport.com/company/torax-medical)

## Its most-cited devices
- K191422: Neural Navigator (2020), cited by 4

## Recent decisions
- K251653: SPRY TMS Therapy System (0550) (Feb 20, 2026)
- K233751: Milieve (YPS-301BD) (Jun 3, 2024)
- K234080: MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (Mar 25, 2024)
- K192823: Mega-TMS (Aug 13, 2021)
- K191422: Neural Navigator (Apr 6, 2020)
- K170291: IontoDC (May 1, 2017)

Source page: https://510kreport.com/company/soterix-medical