FDA.reportPublic FDA data

510(k) K250070

Device
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
Applicant
Shenzhen Changkun Technology Co., Ltd.
510(k) number
K250070
Product code
HGX
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-26
Date received
2025-01-10
Regulation
884.5160
Classification name
Pump, Breast, Powered
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Qingpeng Wang
Address
101,Bldg. 1, 15# Xiusheng 2nd Rd. , Xiuxin Community, Kengzi St.,Pingshan District Shenzhen CN 518122 518122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.2026-09-03
K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.2026-09-01
K260643Cimilre Dual MaxCimilre Co., Ltd.2026-08-21
K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.2026-08-20
K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.2026-07-24
K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.2026-07-13
K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.2026-06-25
K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.2026-06-18
K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.2026-06-17
K260346Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)Polybell (Guangzhou) Limited2026-06-12
K250129AViTA Breast PumpAvita Corporation2026-06-11
K260864Mother's Nature W1 Warming Wearable Breast PumpShenzhen TPH Technology Co., Ltd.2026-06-09
K260956Spectra Platinum MiniUzinmedicare Co., Ltd.2026-06-04
K254300eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)Anker Innovations Limited2026-05-29
K254244Wearable Breast Pump (Model S39)Shenzhen TPH Technology Co., Ltd.2026-05-21