510(k) DEN250004
DEN250004 is an FDA 510(k) premarket notification submitted by Hai Solutions for the device "QIKCAP System". The FDA issued a decision of De Novo Granted on Dec 23, 2025. The device falls under product code SGX (Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves), a Class II device regulated under 21 CFR 880.6512.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Dec 23, 2025
- Date Received
- Jan 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.