Hai Solutions: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Hai Solutions”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SGX | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | 1 | 0 |
Review panels
- General Hospital (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250004 | De Novo | Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | 2025-12-23 |
Recalls
openFDA lists no recalls under a recalling firm named Hai Solutions.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hai Solutions?
FDA lists 0 510(k) clearances under the applicant name “Hai Solutions”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Hai Solutions?
The most frequent FDA product codes under this applicant name are SGX (Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves, 1).
Next steps
- See all 0 Hai Solutions clearances with predicates and recalls
- Run predicate analysis for product code SGX, Hai Solutions's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.