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510(k) K201152

Electric Breast Pump by Guangdong Horigen Mother & Baby Products Co., Ltd. — Product Code HGX

K201152 is an FDA 510(k) premarket notification submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. for the device "Electric Breast Pump". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Guangdong Horigen Mother & Baby Products Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
April 29, 2020
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 Guangdong Horigen Mother & Baby Products Co., Ltd.

  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K212564 — Electric Breast Pump (May 6, 2022)
  • K201974 — Single-use medical face mask (March 7, 2021)
  • K193449 — Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_ (September 11, 2020)
  • K182413 — Electric Breast Pump (March 7, 2019)
  • K162747 — Proture Double Electric Breast Pump (December 8, 2016)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • 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)

FDA data resources