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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 / K250516

510(k) cleared

SMART M-CELL PRP Concentration System

Miracell Co., Ltd. · Apr 2, 2026 · K250516

FDA cleared the SMART M-CELL PRP Concentration System from Miracell Co., Ltd. on Apr 2, 2026 under K250516, a traditional 510(k). The device falls under product code QBV, Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate, regulated at 21 CFR 862.2050 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Feb 21, 2025. The decision came 405 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Miracell Co., Ltd. has one other decision in the tracker over the last 12 months: K250518 (SMART M-CELL Bone Marrow Concentration System).

Questions & Answers

What did FDA clear under K250516?

K250516 is the FDA 510(k) for SMART M-CELL PRP Concentration System, submitted by Miracell Co., Ltd.. FDA's decision date was Apr 2, 2026, under product code QBV (Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate).

Who makes the SMART M-CELL PRP Concentration System?

Miracell Co., Ltd., based in Seoul, is the applicant of record for K250516.

How long did the K250516 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Apr 2, 2026, 405 days later.

← All decisions in April 2026

Sources