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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 / K250700

510(k) cleared

Pen Injector Needle 32.5

Terumo Corporation · Nov 21, 2025 · K250700

FDA cleared the Pen Injector Needle 32.5 from Terumo Corporation on Nov 21, 2025 under K250700, 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 Mar 7, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Terumo Corporation has one other decision in the tracker over the last 12 months: K252295 (Ryurei).

Questions & Answers

What did FDA clear under K250700?

K250700 is the FDA 510(k) for Pen Injector Needle 32.5, submitted by Terumo Corporation. FDA's decision date was Nov 21, 2025, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Pen Injector Needle 32.5?

Terumo Corporation, based in Shibuya-Ku, Tokyo, is the applicant of record for K250700.

How long did the K250700 review take?

FDA received the submission on Mar 7, 2025 and issued its decision on Nov 21, 2025, 259 days later.

← All decisions in November 2025

Sources