SGX — Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves Class II

FDA Device Classification

Classification Details

Product Code
SGX
Device Class
Class II
Regulation Number
880.6512
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN250004hai solutionsQIKCAP SystemDecember 23, 2025