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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 / December 2025 / K252402

510(k) cleared

Midline Catheter

Terumo Medical Products (Hangzhou) Co., Ltd. · Dec 18, 2025 · K252402

FDA cleared the Midline Catheter from Terumo Medical Products (Hangzhou) Co., Ltd. on Dec 18, 2025 under K252402, a traditional 510(k). The device falls under product code PND, Midline Catheter, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 31, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Terumo Medical Products (Hangzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K252398 (SURFLO Hybria Closed System Safety IV Catheter).

Questions & Answers

What did FDA clear under K252402?

K252402 is the FDA 510(k) for Midline Catheter, submitted by Terumo Medical Products (Hangzhou) Co., Ltd.. FDA's decision date was Dec 18, 2025, under product code PND (Midline Catheter).

Who makes the Midline Catheter?

Terumo Medical Products (Hangzhou) Co., Ltd., based in Hangzhou, is the applicant of record for K252402.

How long did the K252402 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Dec 18, 2025, 140 days later.

← All decisions in December 2025

Sources