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510(k) K190465

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

K190465 is an FDA 510(k) premarket notification submitted by Hygeia II Medical Group, Inc. for the device "Evolve Breast Pump". The FDA issued a decision of Substantially Equivalent on Oct 18, 2019. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Hygeia II Medical Group, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 18, 2019
Date Received
Feb 26, 2019
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 Hygeia II Medical Group, Inc.

  • K233136 — Hygeia Express Powered Breast Pump (Mar 13, 2024)
  • K212955 — Fit Pro Breast Pump (Mar 15, 2022)
  • K200406 — Evolve Breast Pump (Mar 18, 2020)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (Jun 18, 2026)

FDA data resources