# Fresca Medical, Inc.

- Location (FDA's records): San Clemente, CA
- FDA decisions: 2 (2018–2020): 1 510(k) clearance and 1 De Novo grant
- Names in FDA's records: Fresca Medical, Inc. (1); Fresca Medical (1)
- Product codes: QBY (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
- DEN170089: Curve Positive Airway Pressure System (2018), cited by 1

## Recent decisions
- K200698: Somnera System (Jun 29, 2020)
- DEN170089: Curve Positive Airway Pressure System (Jun 5, 2018)

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