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510(k) K252192

Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) by Huizhou Lvb Maternal and Infant Supplies Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2025
Date Received
July 14, 2025
Clearance Type
Special
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 Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

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  • K230102 — Smart double sides wearable breast pump, Electric bilateral breast pump (September 21, 2023)

Other clearances for product code HGX

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  • K260033 — Wearable Breast Pump (Model S21A) (April 8, 2026)
  • K254258 — Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y- (April 8, 2026)
  • K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 (April 7, 2026)
  • K250208 — SPECTRA Wearable 2 (April 6, 2026)
  • K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (April 3, 2026)
  • K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) (March 12, 2026)
  • K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, (March 9, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)