WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / October 2025 / K251838

510(k) cleared

Introducer Sheath Set

Cardiocycle Medical(Suzhou) Co., Ltd. · Oct 21, 2025 · K251838

FDA cleared the Introducer Sheath Set from Cardiocycle Medical(Suzhou) Co., Ltd. on Oct 21, 2025 under K251838, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 16, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cardiocycle Medical(Suzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K254248 (Introducer Sheath Set).

Questions & Answers

What did FDA clear under K251838?

K251838 is the FDA 510(k) for Introducer Sheath Set, submitted by Cardiocycle Medical(Suzhou) Co., Ltd.. FDA's decision date was Oct 21, 2025, under product code DYB (Introducer, Catheter).

Who makes the Introducer Sheath Set?

Cardiocycle Medical(Suzhou) Co., Ltd., based in Suzhou, Jiangsu, is the applicant of record for K251838.

How long did the K251838 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Oct 21, 2025, 127 days later.

← All decisions in October 2025

Sources