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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / DEN250004

510(k) cleared

QIKCAP System

Hai Solutions · Dec 23, 2025 · DEN250004 · In the directory

FDA cleared the QIKCAP System from Hai Solutions on Dec 23, 2025 under DEN250004, a direct 510(k). The device falls under product code SGX, Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves, regulated at 21 CFR 880.6512 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 30, 2025. The decision came 327 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hai Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250004?

DEN250004 is the FDA 510(k) for QIKCAP System, submitted by Hai Solutions. FDA's decision date was Dec 23, 2025, under product code SGX (Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves).

Who makes the QIKCAP System?

Hai Solutions, based in Carlsbad, CA, is the applicant of record for DEN250004. The company is listed in the MedDevice Startups directory.

How long did the DEN250004 review take?

FDA received the submission on Jan 30, 2025 and issued its decision on Dec 23, 2025, 327 days later.

← All decisions in December 2025

Sources

In the startup directory

HAI Solutions

Drug Delivery & Infusion · Carlsbad, CA