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510(k) K252583

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) by A Cute Baby, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
August 15, 2025
Clearance Type
Abbreviated
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 A Cute Baby, Inc.

  • K200712 — Rumble Tuff Electric Breast Pump (April 17, 2020)

Other clearances for product code HGX

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  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (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)
  • K251932 — Spectra Platinum (November 25, 2025)