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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 / October 2025 / K251977

510(k) cleared

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)

Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Oct 22, 2025 · K251977

FDA cleared the electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) from Ningbo Youhe Electrical Appliance Technology Co., Ltd. on Oct 22, 2025 under K251977, 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 Jun 27, 2025. The decision came 117 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 Ningbo Youhe Electrical Appliance Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251977?

K251977 is the FDA 510(k) for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X), submitted by Ningbo Youhe Electrical Appliance Technology Co., Ltd.. FDA's decision date was Oct 22, 2025, under product code HGX (Pump, Breast, Powered).

Who makes the electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

Ningbo Youhe Electrical Appliance Technology Co., Ltd., based in Cixi, is the applicant of record for K251977.

How long did the K251977 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Oct 22, 2025, 117 days later.

← All decisions in October 2025