# Somnics, Inc.

- Location (FDA's records): Hsinchu County, TW
- FDA decisions: 2 (2016–2023): 2 510(k) clearances
- Product codes: LRK (1), OZR (1)
- Predicates its devices cite: 2 (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
- Tomed Dr. Toussaint GmbH: 1 (https://510kreport.com/company/tomed-dr-toussaint)
- Somnice, Inc.: 1 (https://510kreport.com/company/somnice)

## Recent decisions
- K220907: The iNAP One Sleep Therapy System (Jun 16, 2023)
- K152660: Hypnospad (Nov 9, 2016)

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