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Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

K250070 Class II Traditional
Decision Date
2026-06-26
Sponsor / Applicant
Shenzhen Changkun Technology Co., Ltd.

Technical Specification

510(k) Submission ID K250070
Product Code HGX
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.5160
Decision Date 2026-06-26
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) received FDA 510(k) clearance under submission number K250070, sponsored by Shenzhen Changkun Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-06-26.

Classification & Regulation

This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.