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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: FMQ FDA class 1

    Restraint, Protective

    General Hospital

    View full classification →

    The Protective Restraint is a device used in clinical settings to restrict patient movement, typically to prevent self-harm or interference with medical treatment, in patients who cannot cooperate with care. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMQ, regulated under 21 CFR 880.6760 in the General Hospital specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PROTECTIVE RESTRAINT
    STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
    CENTURION PROTECTIVE RESTRAINT, SCR SERIES
    COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
    INFANT LIMB HOLDER, MODELS 306080 & 306081
    CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
    BIOTHANE PATIENT RESTRAINT
    VAGABOND SOFT RESTRAINT SYSTEM
    HEELBO WAIST AND CHEST VEST
    PEDO CUSH PEDO CUDDLE
    FULL BODY RESTRAINT SYSTEM
    PATIENT RESTRAINT
    PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
    PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
    DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
    PROVEST-PROTECTIVE RESTRAINT
    RESTRAINTS (VESTS AND JACKETS)
    PATIENT RESTRAINT
    PATIENT RESTRAINTS
    PATIENT RESTRAINTS
    PATIENT RESTRAINTS
    SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE
    PEDIATRIC LIMB HOLDER
    RESTRICTIVE LIMB HOLDER
    DISPOSABLE LIMB HOLDER
    TUXEDO VEST RESTRAINT
    ROLL BELTS
    PELVIC HOLDER
    THE WRAP IMMOBILIZATION SYSTEM
    PATIENT RESTRAINTS
    WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
    POSEY STRAIGHT JACKETS
    QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
    PROTECTIVE RESTRAINT (WAIST HOLDER)
    JACKETS AND VESTS
    MULTIPLE BELTS
    SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS
    RESTRAINT ACCESSORIES
    PROTECTIVE RESTRAINT (PROTECTIVE MITT)
    PROTECTIVE RESTRAINT (VEST RESTRAINT)
    PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
    COMFOR FOAM LIMB HOLDERS- SINGLE STRAP
    SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
    ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
    SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
    ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
    24448-010 SECURE-ALL FINGER CONTROL MITT
    24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
    POSEY LAPTOP TRAYS
    PEDIATRIC LIMB HOLDERS

    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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