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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 / April 2026 / K250234

510(k) cleared

SMARTeZ Elastomeric Infusion Pump (RS series)

Epic Medical Pte. , Ltd. · Apr 24, 2026 · K250234

FDA cleared the SMARTeZ Elastomeric Infusion Pump (RS series) from Epic Medical Pte. , Ltd. on Apr 24, 2026 under K250234, a traditional 510(k). The device falls under product code MEB, Pump, Infusion, Elastomeric, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 27, 2025. The decision came 452 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), K251722 (ProSeal Transfer Injector (421120, 421130, 421140)).

Questions & Answers

What did FDA clear under K250234?

K250234 is the FDA 510(k) for SMARTeZ Elastomeric Infusion Pump (RS series), submitted by Epic Medical Pte. , Ltd.. FDA's decision date was Apr 24, 2026, under product code MEB (Pump, Infusion, Elastomeric).

Who makes the SMARTeZ Elastomeric Infusion Pump (RS series)?

Epic Medical Pte. , Ltd., based in Singapore, is the applicant of record for K250234.

How long did the K250234 review take?

FDA received the submission on Jan 27, 2025 and issued its decision on Apr 24, 2026, 452 days later.

← All decisions in April 2026

Sources