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510(k) K252630

Electric Breast Pump (HL-3060, F5113) by Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2025
Date Received
August 20, 2025
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 Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

  • K252629 — Electric Breast Pump (HL-3058, F5112) (October 27, 2025)
  • K240218 — Electric Breast Pump (F5055) (October 17, 2024)

Other clearances for product code HGX

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  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)