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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: FXX FDA class 2

    Mask, Surgical

    General, Plastic Surgery

    View full classification →

    A surgical mask is a loose-fitting, disposable face covering worn by surgical personnel to reduce the transmission of microorganisms from the wearer to the surgical field, protecting the sterile environment and the patient. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FXX, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
    Surgical Face Mask (Ear mount)
    Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
    Disposable Surgical Face Mask (3P00B, C2900)
    Disposable Medical Face Mask
    KP Protective Face Mask
    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    PRIMED Surgical and Procedure Masks
    Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
    Procedure mask/Surgical mask/Face mask
    Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
    Aurelia Surgical Mask ASTM Level-3 (2130)
    Surgical Face Mask (Tie on/ Ear loops)
    PRIMED Surgical Masks and PRIMED Procedure Masks
    Medical surgical mask
    FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
    FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
    Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
    Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
    HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
    Grande Medical Masks, Model SF-600
    HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
    Disposable Medical Face Mask (M643BE)
    R&G Surgical Mask
    Medical Surgical Mask
    HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)
    Hygenix
    Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
    Biodegradable Medical surgical mask
    Surgical face mask
    Surgical Face Masks, Model: EFMDS-L50Pn BLU
    3 Layer Surgical Mask (134252531)
    Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
    Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
    Surgical Face Mask (L 175*95mm)
    Disposable Medical Mask
    Disposable Surgical Face Mask
    Medline Surgical Face Mask and Medline Procedural Face Mask
    Surgical Face Mask
    PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
    Savvy Surgical Mask - Level 3
    Procedure mask/Surgical mask/Face mask
    Disposable 4 Layers Surgical Face Mask
    Medical Protective Masks
    Ideal Med Pro 3-Ply Disposable Face Mask
    Disposable Surgical Face Mask
    Surgical Face Mask
    Medical Disposable Face Masks
    Surgical Mask
    PM Excellence SEQUR 100 Surgical Face Mask

    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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