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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: MSH FDA class 2

    Respirator, Surgical

    General, Plastic Surgery

    View full classification →

    A Surgical Respirator is a medical-grade face mask that provides filtration of airborne particles and surgical aerosols, protecting both patients and healthcare workers from contamination during surgical or clinical procedures. When it is intended to prevent specific diseases or infections, or labeled as filtering surgical aerosols, it is not exempt and is classified as FDA Class 2 requiring 510(k) clearance; a surgical N95 respirator meeting these criteria falls under this classification. The product code is MSH, regulated under 21 CFR 878.4040, reviewed by the General and Plastic Surgery panel. This device is not an implant and is not life-sustaining.

    510(k) Clearances

    35 matches
    K Number
    Device Name
    Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
    Master-Frank N95 Particulate Respirator
    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
    N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
    Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
    3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
    BARRIER N95 PARTICULATE RESPIRATOR
    PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
    MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
    SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
    N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
    DS N95 SURGICAL MASKS AND FLAT SURGICAL
    HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
    N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
    AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511C
    DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
    N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
    WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
    WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095
    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
    SHANGHAI GANGHAI MODEL GIKO 1400
    PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
    RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
    INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
    MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
    PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
    PCM 2000; ISOLAIR APR MODEL 2735
    ISOLAIR APR TYPE N95

    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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