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510(k) K201903

Electric breast pump (Models: RH-228 and RH-338) by Cixi Ruihong Electric Appliance Co., Ltd. — Product Code HGX

K201903 is an FDA 510(k) premarket notification submitted by Cixi Ruihong Electric Appliance Co., Ltd. for the device "Electric breast pump (Models: RH-228 and RH-338)". The FDA issued a decision of Substantially Equivalent on Apr 9, 2021. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Cixi Ruihong Electric Appliance Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 9, 2021
Date Received
Jul 8, 2020
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 Cixi Ruihong Electric Appliance Co., Ltd.

  • K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) (Apr 3, 2026)

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: SCF5 (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