Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))— 510(k) K261298
Substantially EquivalentGuangdong Youmeng Electrical Technology Co., Ltd.
FDA 510(k) clearance K261298 for Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)), Substantially Equivalent on 2026-08-20. Applicant: Guangdong Youmeng Electrical Technology Co., Ltd.. Device class: 2.
Summary
Guangdong Youmeng Electrical Technology's Wearable Electric Breast Pump lists four models: YM-8837, YM-8838, YM-8856 (H03), and YM-8809 (S42). It's filed under product code HGX, powered breast pumps.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it was a Traditional 510(k).
Youmeng filed from Foshan, China. The decision came 122 calendar days after receipt (April 20 to August 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Guangdong Youmeng Electrical Technology Co., Ltd.
- Product code
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Recent devices under product code HGX
view allMore clearances from Guangdong Youmeng Electrical Technology Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
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