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

FDA 510(k) K261298 · Guangdong Youmeng Electrical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK261298

Submission

Device name
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Applicant
Guangdong Youmeng Electrical Technology Co., Ltd.
Foshan, CN
Received
April 20, 2026
Decision date
August 20, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HGX – Pump, Breast, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5160
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HGX

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K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional Philips Consumer Lifestyle B.V.09/03/2026SE
K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional Guangdong Horigen Mother & Baby Products Co., Ltd.09/01/2026SE
K260643Cimilre Dual MaxHGX · Traditional Cimilre Co., Ltd.08/21/2026SE
K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)HGX · Traditional Shenzhen TPH Technology Co., Ltd.07/24/2026SE
K261199Wearable Breast Pump (Model S32A)HGX · Traditional Shenzhen TPH Technology Co., Ltd.07/13/2026SE
K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional Shenzhen Changkun Technology Co., Ltd.06/26/2026SE
K261025Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional Shenzhen Qinyi Electronic Technology Co., Ltd.06/25/2026SE
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional Shenzhen Root Innovation Technology Co., Ltd.06/18/2026SE
K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional Shenzhen Root Innovation Technology Co., Ltd.06/17/2026SE
K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129…HGX · Traditional Polybell (Guangzhou) Limited06/12/2026SE

More from Polybell (Guangzhou) Limited

510(k)DeviceDecision
K252754Wearable Electric Breast Pump (YM-8803)HGX · Traditional 12/19/2025SE
K252342Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)HGX · Traditional 12/19/2025SE
K232466Electric Breast Pump, model: YM-8166HGX · Traditional 01/19/2024SE

Questions and answers

When was Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) cleared by the FDA?

Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (K261298) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 122 days after the submission was received.

What is the product code of K261298?

The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.