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510(k) K212955

Fit Pro Breast Pump by Hygeia II Medical Group, Inc. — Product Code HGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2022
Date Received
September 16, 2021
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 Hygeia II Medical Group, Inc.

  • K233136 — Hygeia Express Powered Breast Pump (March 13, 2024)
  • K200406 — Evolve Breast Pump (March 18, 2020)
  • K190465 — Evolve Breast Pump (October 18, 2019)

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  • 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)