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510(k) K231595

Electric Breast Pump by Shenzhen Changkun Technology Co., Ltd. — Product Code HGX

K231595 is an FDA 510(k) premarket notification submitted by Shenzhen Changkun Technology Co., Ltd. for the device "Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Shenzhen Changkun Technology Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
June 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Shenzhen Changkun Technology Co., Ltd.

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (May 6, 2026)
  • K221798 — Finger Pulse Oximeter, Model: X1906P (May 4, 2023)
  • K193387 — Arm Electronic Sphygmomanometer (January 27, 2021)
  • K193386 — Wrist Electronic Sphygmomanometer (January 27, 2021)
  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (June 17, 2020)

Other clearances for product code HGX

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • K250129 — AViTA Breast Pump (June 11, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
  • K254244 — Wearable Breast Pump (Model S39) (May 21, 2026)

FDA data resources