Hai Solutions - FDA 510(k) Cleared Devices

Hai Solutions, develops innovative medical devices addressing intravenous care and vascular access challenges. The company, with a manufacturing facility in Carlsbad, US, focuses on preventing contamination in clinical settings including operating rooms, emergency departments, and intensive care units.

Hai Solutions has submitted 1 FDA 510(k) application(s) and received 0 clearance(s) in the General Hospital device category. The company's regulatory activity began in 2025. This represents a historical record of early-stage FDA engagement.

The company's product portfolio targets hospital-onset bacteremia and microbial contamination through vascular access technology. Notable innovations include ultraviolet light-based microbial reduction systems for needleless IV connectors and multiport delivery devices designed to improve clinical workflows and patient safety.

Explore Hai Solutions' device submissions, product codes, and regulatory clearance details in the database.