BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)

    K Number: K254254 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    12
    Review Days
    171

    Basic Information

    Device Name
    Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
    K Number
    K254254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Received
    December 29, 2025
    Decision Date
    June 18, 2026
    Product Code
    HGX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HGX Pump, Breast, Powered

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    Other Clearances by Shenzhen Root Innovation Technology Co., Ltd.

    K Number Device Name
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    K260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)
    K253914 Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
    K254258 Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)
    K253946 Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)
    K253934 Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
    K253283 Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
    K251394 Momcozy Wearable Breast Pump (BP223)
    K241680 Momcozy Wearable Breast Pump (BP311)
    Search all 12 clearances from Shenzhen Root Innovation Technology Co., Ltd. →