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 / June 2026 / K260301

510(k) cleared

Vial Adapter

Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Jun 5, 2026 · K260301

FDA cleared the Vial Adapter from Hangzhou Qiantang Longyue Biotechnology Co., Ltd. on Jun 5, 2026 under K260301, a traditional 510(k). The device falls under product code LHI, Set, I.V. Fluid Transfer, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 30, 2026. The decision came 126 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hangzhou Qiantang Longyue Biotechnology Co., Ltd. has one other decision in the tracker over the last 12 months: K260933 (Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)).

Questions & Answers

What did FDA clear under K260301?

K260301 is the FDA 510(k) for Vial Adapter, submitted by Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. FDA's decision date was Jun 5, 2026, under product code LHI (Set, I.V. Fluid Transfer).

Who makes the Vial Adapter?

Hangzhou Qiantang Longyue Biotechnology Co., Ltd., based in Hangzhou, is the applicant of record for K260301.

How long did the K260301 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Jun 5, 2026, 126 days later.

← All decisions in June 2026