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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 / September 2025 / K250205

510(k) cleared

Babio® Virus Transport Kit (Non-inactivating)

Jinan Babio Biotechnology Co., Ltd. · Sep 22, 2025 · K250205

FDA cleared the Babio® Virus Transport Kit (Non-inactivating) from Jinan Babio Biotechnology Co., Ltd. on Sep 22, 2025 under K250205, a traditional 510(k). The device falls under product code JSM, Culture Media, Non-Propagating Transport, regulated at 21 CFR 866.2390 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 24, 2025. The decision came 241 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 Jinan Babio Biotechnology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250205?

K250205 is the FDA 510(k) for Babio® Virus Transport Kit (Non-inactivating), submitted by Jinan Babio Biotechnology Co., Ltd.. FDA's decision date was Sep 22, 2025, under product code JSM (Culture Media, Non-Propagating Transport).

Who makes the Babio® Virus Transport Kit (Non-inactivating)?

Jinan Babio Biotechnology Co., Ltd., based in Jinan, is the applicant of record for K250205.

How long did the K250205 review take?

FDA received the submission on Jan 24, 2025 and issued its decision on Sep 22, 2025, 241 days later.

← All decisions in September 2025