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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: HGX FDA class 2

    Pump, Breast, Powered

    Obstetrics/Gynecology

    View full classification →

    The Powered Breast Pump is an electrically operated device used to express breast milk by applying cyclical suction to the nipple, used by lactating women who are unable to breastfeed directly or need to maintain milk supply. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGX, regulated under 21 CFR 884.5160, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)
    Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
    Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
    AViTA Breast Pump
    Mother's Nature W1 Warming Wearable Breast Pump
    Spectra Platinum Mini
    eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
    Wearable Breast Pump (Model S39)
    Electric Breast Pump (HL-3058 II Pro)
    Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
    Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
    Freestyle Mini Hands-free
    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)
    Wearable Breast Pump (Model S21A)
    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)
    SPECTRA Wearable 2
    Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
    Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
    Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
    Wearable Breast Pump (Model W12)
    Wearable Breast Pump (Model W2)
    Motion InBra (YM-8801) wearable breast pump
    Spectra S1 Pro; Spectra S2 Pro
    Pump In Style® Pro+
    Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
    Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
    Wearable Electric Breast Pump (YM-8803)
    Spectra Platinum
    Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
    Electric Breast Pump (HL-3060, F5113)
    Electric Breast Pump (HL-3058, F5112)
    electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
    Hi bebe super (BT-150B)
    Magic InBra
    Momcozy Wearable Breast Pump (BP223)
    Wearable Breast Pump (Model S33)
    Wearable Breast Pump (Model W6)
    Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
    eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
    Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)
    Thrive 2-in-1 Breast Pump (Model P3)
    Wearable Breast Pump (Model S21)
    Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
    Motif Aura Glow breast pump (Model Motif Aura Glow)
    Wearable breast pump (model S12A)
    Lacevo Wearable Breast Pump (Model S70)
    eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
    Ameda GLO Wearable Breast Pump (Model W8S)
    Wearable breast pump (model W8)
    VIVACE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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