FDA Product Code SGX: Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves
An Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves Is A Device That Uses Ultraviolet Light To Irradiate Luer-activated Valves (e.g., As Used For Intravascular Administration). The Device Is Intended To Supplement The Manual, Physical Microbicidal Treatment Of Luer-activated Valves By Providing Limited Microbial Reduction, And Is Not Intended To Disinfect Or Replace Manual Microbicidal Treatment.
Leading manufacturers include Hai Solutions.
FDA 510(k) Cleared Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves Devices (Product Code SGX)
About Product Code SGX - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGX since 2025, with 0 receiving FDA clearance (average review time: 327 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SGX devices are reviewed by the General Hospital panel. Browse all General Hospital devices →