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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 / October 2025 / K251715

510(k) cleared

FlowArt® Vial Access Device Vented

Asset Medikal · Oct 14, 2025 · K251715

FDA cleared the FlowArt® Vial Access Device Vented from Asset Medikal on Oct 14, 2025 under K251715, a traditional 510(k). The device falls under product code LHI, Set, I.V. Fluid Transfer, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 4, 2025. The decision came 132 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 Asset Medikal in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251715?

K251715 is the FDA 510(k) for FlowArt® Vial Access Device Vented, submitted by Asset Medikal. FDA's decision date was Oct 14, 2025, under product code LHI (Set, I.V. Fluid Transfer).

Who makes the FlowArt® Vial Access Device Vented?

Asset Medikal, based in Istanbul, is the applicant of record for K251715.

How long did the K251715 review take?

FDA received the submission on Jun 4, 2025 and issued its decision on Oct 14, 2025, 132 days later.

← All decisions in October 2025