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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 / December 2025 / K251722

510(k) cleared

ProSeal Transfer Injector (421120, 421130, 421140)

Epic Medical Pte. , Ltd. · Dec 5, 2025 · K251722

FDA cleared the ProSeal Transfer Injector (421120, 421130, 421140) from Epic Medical Pte. , Ltd. on Dec 5, 2025 under K251722, a special 510(k). The device falls under product code ONB, Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, 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 184 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: K252987 (ADRx Admixture Device), K250234 (SMARTeZ Elastomeric Infusion Pump (RS series)).

Questions & Answers

What did FDA clear under K251722?

K251722 is the FDA 510(k) for ProSeal Transfer Injector (421120, 421130, 421140), submitted by Epic Medical Pte. , Ltd.. FDA's decision date was Dec 5, 2025, under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System).

Who makes the ProSeal Transfer Injector (421120, 421130, 421140)?

Epic Medical Pte. , Ltd., based in Singapore, is the applicant of record for K251722.

How long did the K251722 review take?

FDA received the submission on Jun 4, 2025 and issued its decision on Dec 5, 2025, 184 days later.

← All decisions in December 2025

Sources