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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 / December 2025 / K252754

510(k) cleared

Wearable Electric Breast Pump (YM-8803)

Guangdong Youmeng Electrical Technology Co., Ltd. · Dec 19, 2025 · K252754

FDA cleared the Wearable Electric Breast Pump (YM-8803) from Guangdong Youmeng Electrical Technology Co., Ltd. on Dec 19, 2025 under K252754, 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 Aug 29, 2025. The decision came 112 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangdong Youmeng Electrical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252342 (Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)).

Questions & Answers

What did FDA clear under K252754?

K252754 is the FDA 510(k) for Wearable Electric Breast Pump (YM-8803), submitted by Guangdong Youmeng Electrical Technology Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable Electric Breast Pump (YM-8803)?

Guangdong Youmeng Electrical Technology Co., Ltd., based in Foshan, is the applicant of record for K252754.

How long did the K252754 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Dec 19, 2025, 112 days later.

← All decisions in December 2025

Sources