Data / Medical devices / United States / Hai Solutions Inc
Hai Solutions Inc: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
Hai Solutions Inc is registered with the FDA (registration 3043650423) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043650423
- Address
- 1902 Wright Pl Ste 200, Carlsbad, CA, United States, 92008
- Owner or operator
- HAI Solutions Inc (10095256)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 12, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves | SGX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2025 | DEN250004 | QIKCAP System | SGX | Unknown | Hai Solutions | accessdata.fda.gov |
Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.