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510(k) K212884

Electric breast pump by Dongguan Rongfeng Medical Co., Ltd. — Product Code HGX

K212884 is an FDA 510(k) premarket notification submitted by Dongguan Rongfeng Medical Co., Ltd. for the device "Electric breast pump". The FDA issued a decision of Substantially Equivalent on Jan 20, 2022. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 20, 2022
Date Received
Sep 10, 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
510(k)

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  • 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)
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FDA data resources