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510(k) K232774

Wearable Breast Pump,Model S18 by Ningbo Dearevery Electronic Technology Co., Ltd. — Product Code HGX

K232774 is an FDA 510(k) premarket notification submitted by Ningbo Dearevery Electronic Technology Co., Ltd. for the device "Wearable Breast Pump,Model S18". The FDA issued a decision of Substantially Equivalent on June 6, 2024. 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
June 6, 2024
Date Received
September 11, 2023
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

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  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)
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FDA data resources