Wearable breast pump (Model: XN/MD-2249BS, ZFHF)

FDA cleared the Wearable breast pump (Model: XN/MD-2249BS, ZFHF) from Guangdong Horigen Mother & Baby Products Co., Ltd. on Sep 1, 2026 under K262774, a traditional 510(k) reviewed through the Third Party Review Program. 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 4, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guangdong Horigen Mother & Baby Products Co., Ltd. in the last 12 months of the tracker.