510(k) DEN250004

QIKCAP System by Hai Solutions — Product Code SGX

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 23, 2025
Date Received: January 30, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
Device Class: Class II
Regulation Number: 880.6512
Review Panel: HO
Submission Type

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.