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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 / K250070

510(k) cleared

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

Shenzhen Changkun Technology Co., Ltd. · Jun 26, 2026 · K250070

FDA cleared the Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) from Shenzhen Changkun Technology Co., Ltd. on Jun 26, 2026 under K250070, a traditional 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 Jan 10, 2025. The decision came 532 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Changkun Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252552 (Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)).

Questions & Answers

What did FDA clear under K250070?

K250070 is the FDA 510(k) for Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3), submitted by Shenzhen Changkun Technology Co., Ltd.. FDA's decision date was Jun 26, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)?

Shenzhen Changkun Technology Co., Ltd., based in Shenzhen, is the applicant of record for K250070.

How long did the K250070 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Jun 26, 2026, 532 days later.

← All decisions in June 2026

Sources