# Somnetics International, Inc.

- Location (FDA's records): New Brighton, MN
- FDA decisions: 3 (2013–2018): 3 510(k) clearances
- Product codes: BZD (2), BTT (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 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
- Aeiomed, Inc.: 1 (https://510kreport.com/company/aeiomed)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Resmed, Ltd.: 1 (https://510kreport.com/company/resmed)

## Its most-cited devices
- K132127: Transcend Auto (2013), cited by 1
- K131388: Transcend Heated Humidifier (2013), cited by 1

## Recent decisions
- K180388: Transcend 365 miniCPAP System (Nov 30, 2018)
- K132127: Transcend Auto (Oct 17, 2013)
- K131388: Transcend Heated Humidifier (Sep 26, 2013)

Source page: https://510kreport.com/company/somnetics-international
