# Ototronix, LLC

- Location (FDA's records): St. Paul, MN
- FDA decisions: 3 (2001–2014): 2 510(k) clearances and 1 original PMA approval
- Product codes: NEA (1), GWN (1), MPV (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (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
- Corinthian Medical, Ltd.: 1 (https://510kreport.com/company/corinthian-medical)
- Envoy Medical Corporation: 1 (https://510kreport.com/company/envoy-medical)
- Fall Prevention Technologies, LLC: 1 (https://510kreport.com/company/fall-prevention-technologies)
- Ics Medical Corp.: 1 (https://510kreport.com/company/ics-medical)
- Interacoustics A/S: 1 (https://510kreport.com/company/interacoustics-a-s)

## Recent decisions
- K140644: Procem (Jun 19, 2014)
- K130201: Nystagram Video Nystagmography System (Apr 26, 2013)
- P010023: Soundtec Direct System (Sep 7, 2001)

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