# Sonitus Medical, Inc.

- Location (FDA's records): San Carlos, CA
- FDA decisions: 2 (2011–2011): 2 510(k) clearances
- Product codes: LXB (2)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cochlear Bone Anchored Systems AB: 2 (https://510kreport.com/company/cochlear-bone-anchored-systems)
- Wordcomp International Communication Group (Wicg): 1 (https://510kreport.com/company/wordcomp-international-communication-group-wicg)
- Entific Medical Systems, Inc.: 1 (https://510kreport.com/company/entific-medical-systems)
- United Hearing Systems, Inc.: 1 (https://510kreport.com/company/united-hearing-systems)
- Ear Technology Corp.: 1 (https://510kreport.com/company/ear-technology)

## Its most-cited devices
- K100649: Soundbite Hearing System by Sonitus (2011), cited by 1

## Recent decisions
- K110831: Soundbite Hearing System by Sonitus Medical (Jun 21, 2011)
- K100649: Soundbite Hearing System by Sonitus (Jan 14, 2011)

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