# Iris USA

- Location (FDA's records): Pleasant Prairie, WI
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: FXX (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K230380: Surgical Face Masks, Model: EFMDS-L50Pn BLU (Aug 3, 2023)

Source page: https://510kreport.com/company/iris-usa