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The Tracker / August 2026 / K261298

510(k) cleared

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))

Guangdong Youmeng Electrical Technology Co., Ltd. · Aug 20, 2026 · K261298

FDA cleared the Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) from Guangdong Youmeng Electrical Technology Co., Ltd. on Aug 20, 2026 under K261298, 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 Apr 20, 2026. The decision came 122 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 2 other decisions in the tracker over the last 12 months: K252342 (Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)), K252754 (Wearable Electric Breast Pump (YM-8803)).

Questions & Answers

What did FDA clear under K261298?

K261298 is the FDA 510(k) for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)), submitted by Guangdong Youmeng Electrical Technology Co., Ltd.. FDA's decision date was Aug 20, 2026, under product code HGX (Pump, Breast, Powered).

Who makes the Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))?

Guangdong Youmeng Electrical Technology Co., Ltd., based in Foshan, is the applicant of record for K261298.

How long did the K261298 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Aug 20, 2026, 122 days later.

← All decisions in August 2026

Sources