Cleared Traditional

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

K252342 · Guangdong Youmeng Electrical Technology Co., Ltd. · Obstetrics & Gynecology
Dec 2025
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K252342 is an FDA 510(k) clearance for the Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Guangdong Youmeng Electrical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 19, 2025, 144 days after receiving the submission on July 28, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K252342 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2025
Decision Date December 19, 2025
Days to Decision 144 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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