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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: FRG FDA class 2

    Wrap, Sterilization

    General Hospital

    View full classification →

    A sterilization wrap is a material used to enclose sterilized instruments or supplies, maintaining sterility until the point of use in clinical or surgical settings. 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 FRG, regulated under 21 CFR 880.6850, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Sterilization Pouch and Roll
    GCI Sterilization Wrappers
    Self Sealing Sterilization Pouches
    Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)
    Sterilization Package/Reel
    Medicom Sterilization Pouch and Reel
    Sterilization Pouches and Reels
    CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)
    Safe Secure Sterilization Pouches and Rolls
    PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    Perpak™ Sterilization Tyvek Pouch
    Medline Reusable Sterilization Wrappers
    HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
    HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)
    Medicom Sterilization Wrap
    Steriking® Pouch for Robotic Instruments
    PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
    Dukal SMS Sterilization Wrap
    Reliance® Fusion Sterilization Wraps
    Steriking® LT-Blueline Pouches with Tyvek®
    Steriking® LT-Blueline Pouches with Tyvek®
    Sterilization Wrap
    Vis-U-All Low Temperature Sterilization Pouches
    Tyvek Roll with CI for STERLINK Sterilizer
    Sterilization Wrap
    Sterilization Pouch and Roll
    Steriking LT-Blueline Pouches with Tyvek
    SteriKing LT-Blueline Pouches with Tyvek
    Gemini Sterilization Wrap
    Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
    Solidence Multipockets
    HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
    Steriking Packaging for Medical Devices
    CareGUARD Sterilization Wrap
    Sterilization Wraps
    Steiking Packaging for Medical Devices
    SterileRight sterilization pouch and roll
    Tyvek(R) Roll with CI for STERLINKTM Sterilizer
    Turbett Instrument Pod
    SIGMA Sterilization Pouch and Roll
    Sterisheet Sterilization Wrap
    Tyvek Sterilization Pouches with Chevron Seal
    Turbett Instrument Pod
    Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
    Gemini Titan Sterilization Wrap
    Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
    Halyard ONE-STEP* Sterilization Wrap
    Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
    Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
    JAMBRO Single Core A Sterilization wrap

    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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