510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250004Unknown

QIKCAP System

Hai Solutions Inc, Carlsbad CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250004 is the FDA 510(k) clearance record for QIKCAP System, a class II device, cleared for Hai Solutions on under FDA product code SGX (Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves). FDA's definition for product code SGX reads: "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...". FDA records list one 510(k) clearance for Hai Solutions. As of , FDA records show no recalls naming DEN250004.

Clearance record

Decision date
Received
(327 days to decision)
Product code
SGX Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
Regulation
21 CFR 880.6512
Device class
Class II
Review panel
General Hospital
Applicant
Hai Solutions 1902 Wright Pl., Carlsbad CA
Third party review
No

Clearances, product code SGX

Trailing 12 months
1 clearance under product code SGX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260