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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 / June 2026 / K252987

510(k) cleared

ADRx Admixture Device

Epic Medical Pte. , Ltd. · Jun 12, 2026 · K252987

FDA cleared the ADRx Admixture Device from Epic Medical Pte. , Ltd. on Jun 12, 2026 under K252987, 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 Sep 18, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Epic Medical Pte. , Ltd. has 2 other decisions in the tracker over the last 12 months: K250234 (SMARTeZ Elastomeric Infusion Pump (RS series)), K251722 (ProSeal Transfer Injector (421120, 421130, 421140)).

Questions & Answers

What did FDA clear under K252987?

K252987 is the FDA 510(k) for ADRx Admixture Device, submitted by Epic Medical Pte. , Ltd.. FDA's decision date was Jun 12, 2026, under product code LHI (Set, I.V. Fluid Transfer).

Who makes the ADRx Admixture Device?

Epic Medical Pte. , Ltd., based in Singapore, is the applicant of record for K252987.

How long did the K252987 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Jun 12, 2026, 267 days later.

← All decisions in June 2026

Sources