# Hai Solutions

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 1 (2025–2025): 1 De Novo grant
- Product codes: SGX (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
- DEN250004: QIKCAP System (Dec 23, 2025)

Source page: https://510kreport.com/company/hai-solutions