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510(k) K262774

Wearable breast pump (Model: XN/MD-2249BS, ZFHF) by Guangdong Horigen Mother & Baby Products Co., Ltd. — Product Code HGX

K262774 is an FDA 510(k) premarket notification submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. for the device "Wearable breast pump (Model: XN/MD-2249BS, ZFHF)". The FDA issued a decision of Substantially Equivalent on September 1, 2026. 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
September 1, 2026
Date Received
August 4, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

  • K212564 — Electric Breast Pump (May 6, 2022)
  • K201152 — Electric Breast Pump (May 4, 2021)
  • 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)
  • 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)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)

FDA data resources