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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 / October 2025 / K250510

510(k) cleared

Sure-Fine Insulin Syringes

Shina Med Corporation · Oct 15, 2025 · K250510

FDA cleared the Sure-Fine Insulin Syringes from Shina Med Corporation on Oct 15, 2025 under K250510, 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 Feb 21, 2025. The decision came 236 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Shina Med Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250510?

K250510 is the FDA 510(k) for Sure-Fine Insulin Syringes, submitted by Shina Med Corporation. FDA's decision date was Oct 15, 2025, under product code FMF (Syringe, Piston).

Who makes the Sure-Fine Insulin Syringes?

Shina Med Corporation, based in Anseong-Si, is the applicant of record for K250510.

How long did the K250510 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Oct 15, 2025, 236 days later.

← All decisions in October 2025