FDA applicant
Hai Solutions
FDA records 1 decision for Hai Solutions (Carlsbad, CA) in 2025: 1 De Novo grant. All are in product code SGX (Ultraviolet Light-Based Microbial Reduction…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hai Solutions’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2025high 1 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Hai Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report