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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 / November 2025 / K250853

510(k) cleared

Merit Syringe

Merit Medical Systems, Inc. · Nov 4, 2025 · K250853

FDA cleared the Merit Syringe from Merit Medical Systems, Inc. on Nov 4, 2025 under K250853, a special 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 21, 2025. The decision came 228 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Merit Medical Systems, Inc. has 5 other decisions in the tracker over the last 12 months: K261310 (FlexTract Deflectable-Rotational Dilator Sheath Set), K262086 (PreludeSYNC Radial Compression Device), K254073 (StatSeal Disc), K251802 (STAR RF Ablation System).

Questions & Answers

What did FDA clear under K250853?

K250853 is the FDA 510(k) for Merit Syringe, submitted by Merit Medical Systems, Inc.. FDA's decision date was Nov 4, 2025, under product code FMF (Syringe, Piston).

Who makes the Merit Syringe?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K250853.

How long did the K250853 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Nov 4, 2025, 228 days later.

← All decisions in November 2025

Sources