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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 / K251512

510(k) cleared

Hi bebe super (BT-150B)

Bistos Co., Ltd. · Sep 25, 2025 · K251512

FDA cleared the Hi bebe super (BT-150B) from Bistos Co., Ltd. on Sep 25, 2025 under K251512, a special 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on May 16, 2025. The decision came 132 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 Bistos Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251512?

K251512 is the FDA 510(k) for Hi bebe super (BT-150B), submitted by Bistos Co., Ltd.. FDA's decision date was Sep 25, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the Hi bebe super (BT-150B)?

Bistos Co., Ltd., based in Seongnam-Si, is the applicant of record for K251512.

How long did the K251512 review take?

FDA received the submission on May 16, 2025 and issued its decision on Sep 25, 2025, 132 days later.

← All decisions in September 2025