# Somna Therapeutics, LLC

- Location (FDA's records): Germantown, WI
- FDA decisions: 2 (2015–2018): 1 510(k) clearance and 1 De Novo grant
- Product codes: PKA (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN130046: Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device (2015), cited by 1

## Recent decisions
- K173934: Reza Band, Reflux Band (Apr 13, 2018)
- DEN130046: Reza Band (TM) Upper Esophageal (Ues) Sphincter Assist Device (Mar 6, 2015)

Source page: https://510kreport.com/company/somna-therapeutics