BEUDAMED
    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
    Motif Aura Glow breast pump (Model Motif Aura Glow)
    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)
    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
    Momcozy Wearable Breast Pump (BP311)
    Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
    Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
    Electric Breast Pump (F5055)
    Elvie Stride 2
    Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
    BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
    MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)
    Wearable Breast Pump (Model S32)
    Annabella Double Breast Pump (ADO-US23-1000)
    Wearable Breast Pump,Model S18
    Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308)
    Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)
    Duo Hands-free Breast Pump
    VIVACE
    Hygeia Express Powered Breast Pump
    Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
    Perifit Pump
    Electric Breast Pump, model: YM-8166
    Evenflo Premium Double Electric Breast Pump (Model 4018)
    Electric Breast Pump
    Willow Generation 3 Breast Pump
    Smart double sides wearable breast pump, Electric bilateral breast pump
    Annabella Breast Pump
    Wearable Breast Pump (Model S18)
    Compact Wearable Pump
    Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
    Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
    ARDO Bellis
    MilkMate Breast Pump
    Electric breast pump (model: M5)
    imani i2Plus Breast Pump
    Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
    Wearable Breast Pump (Model S1DW)
    CIMILRE Free-T2 Plus
    Smartpump 3.0 Double Electric Breast Pump
    Spectra Wearable
    Wearable breast pump
    Ameda Pearl Electric Breast Pump
    Powered Breast Pump (Models 7V and 7X)
    Wearable Breast Pump (Model S10)

    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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