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510(k) Data Aggregation

    K Number
    K251423

    Validate with FDA (Live)

    Date Cleared
    2026-02-06

    (274 days)

    Product Code
    Regulation Number
    884.5160
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

    Device Description

    The Spectra S1 Pro and Spectra S2 Pro are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Spectra S1 Pro and Spectra S2 Pro are comprised of the following components: pump unit, adapter, wide breast shield, back-flow protector, tubing, silicone valve, bottle cap, bottle screw, nipple, airtight cap, and PP bottle. The device is provided non-sterile.

    The Spectra S1 Pro and Spectra S2 Pro support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.

    Spectra S1 Pro and Spectra S2 Pro includes the following features:

    • Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
    • Expression mode: 1-15 level (50-270 mmHg), cycle speeds (38, 42, 46, 50, 52, 58)
    • Massage mode: 1-5 level (50-180 mmHg), cycle speeds (70, 80, 90, 100, 105)

    The Spectra S1 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2000mAh). The Spectra S2 Pro operates using an AC adapter (100-240V AC, 50/60Hz, DC 12V) only.

    When the backflow protector is assembled between the pump unit and the breast shield, the silicone membrane inside the backflow protector creates a physical barrier by preventing air and milk from flowing back into the pump unit.

    All milk contacting components are compliant with 21 CFR 177.

    AI/ML Overview

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