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THE TAPE

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 / March 2026 / K253622

510(k) cleared

Safety Pen Needle

Ningbo Medsun Medical Co., Ltd. · Mar 18, 2026 · K253622

FDA cleared the Safety Pen Needle from Ningbo Medsun Medical Co., Ltd. on Mar 18, 2026 under K253622, a traditional 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 18, 2025. The decision came 120 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ningbo Medsun Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253605 (Safety Heel Lancet).

Questions & Answers

What did FDA clear under K253622?

K253622 is the FDA 510(k) for Safety Pen Needle, submitted by Ningbo Medsun Medical Co., Ltd.. FDA's decision date was Mar 18, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Safety Pen Needle?

Ningbo Medsun Medical Co., Ltd., based in Ningbo, is the applicant of record for K253622.

How long did the K253622 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 18, 2026, 120 days later.

← All decisions in March 2026

Sources