Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)— 510(k) K250070

Name: FDA 510(k) clearance K250070
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Shenzhen Changkun Technology Co., Ltd.

FDA 510(k) clearance K250070 for Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3), Substantially Equivalent on 2026-06-26. Applicant: Shenzhen Changkun Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Changkun Technology Co., Ltd.
Product code: Code HGX
Device class: Class 2
Regulation: 21 CFR 884.5160
Advisory panel: Obstetrics/Gynecology
Date received: 2025-01-10
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGX

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K260643 — Cimilre Dual Max2026-08-21
K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))2026-08-20
K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)2026-07-24
K261199 — Wearable Breast Pump (Model S32A)2026-07-13
K261025 — Wearable breast pump (QY-101, QY-102, QY-108)2026-06-25

More clearances from Shenzhen Changkun Technology Co., Ltd.

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K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)2026-05-06
K231595 — Electric Breast Pump2023-10-26
K221798 — Finger Pulse Oximeter, Model: X1906P2023-05-04
K193386 — Wrist Electronic Sphygmomanometer2021-01-27
K193387 — Arm Electronic Sphygmomanometer2021-01-27

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.