Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
FDA 510(k) K250070 · Shenzhen Changkun Technology Co., Ltd.
510(k) numberK250070
Submission
- Device name
- Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
- Applicant
- Shenzhen Changkun Technology Co., Ltd.
Shenzhen, CN - Received
- January 10, 2025
- Decision date
- June 26, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/17/2026SE |
| K260346 | Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129…HGX · Traditional | Polybell (Guangzhou) Limited | 06/12/2026SE |
More from Polybell (Guangzhou) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K252552 | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)KPI · Traditional | 05/06/2026SE |
| K231595 | Electric Breast PumpHGX · Traditional | 10/26/2023SE |
| K221798 | Finger Pulse Oximeter, Model: X1906PDQA · Traditional | 05/04/2023SE |
| K193387 | Arm Electronic SphygmomanometerDXN · Traditional | 01/27/2021SE |
| K193386 | Wrist Electronic SphygmomanometerDXN · Traditional | 01/27/2021SE |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503FLL · Traditional | 06/17/2020SE |
Questions and answers
When was Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) cleared by the FDA?
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (K250070) received a 510(k) decision of Substantially Equivalent on June 26, 2026, 532 days after the submission was received.
What is the product code of K250070?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.