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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 Oct 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 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 26, 2023
Date Received
Jun 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
510(k)

Other clearances by Shenzhen Changkun Technology Co., Ltd.

  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 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 (Jan 27, 2021)
  • K193386 — Wrist Electronic Sphygmomanometer (Jan 27, 2021)
  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (Jun 17, 2020)

Other clearances for product code HGX

  • K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)

FDA data resources

Source: FDA 510(k) database entry for K231595. Report a data issue: hello@regdatalab.com.