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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 / June 2026 / K252899

510(k) cleared

Female Culture Device; Male Culture Device; Transfer Device; Access Device

Zhejiang Kindly Medical Device Co., Ltd. · Jun 2, 2026 · K252899

FDA cleared the Female Culture Device; Male Culture Device; Transfer Device; Access Device from Zhejiang Kindly Medical Device Co., Ltd. on Jun 2, 2026 under K252899, a traditional 510(k). The device falls under product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection, regulated at 21 CFR 862.1675 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 11, 2025. The decision came 264 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zhejiang Kindly Medical Device Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252899?

K252899 is the FDA 510(k) for Female Culture Device; Male Culture Device; Transfer Device; Access Device, submitted by Zhejiang Kindly Medical Device Co., Ltd.. FDA's decision date was Jun 2, 2026, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the Female Culture Device; Male Culture Device; Transfer Device; Access Device?

Zhejiang Kindly Medical Device Co., Ltd., based in Wenzhou, is the applicant of record for K252899.

How long did the K252899 review take?

FDA received the submission on Sep 11, 2025 and issued its decision on Jun 2, 2026, 264 days later.

← All decisions in June 2026