BEUDAMED
    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: KZE FDA class 2

    Injector, Fluid, Non-Electrically Powered

    General Hospital

    View full classification →

    The Non-Electrically Powered Fluid Injector is a mechanical device that uses manual or pneumatic force to inject fluids into patients without reliance on an electrical power source, used in settings where controlled fluid delivery is needed without powered equipment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZE, regulated under 21 CFR 880.5430, in the General Hospital medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
    PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
    PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
    LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
    ZETAJET
    PHARMAJET NEEDLE-FREE INJECTION SYSTEM
    AIRGENT, MODEL AG7000010
    COOL.CLICK 2
    BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
    COOL.CLICK
    GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000
    HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
    BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
    AVANT GUARDIAN 101
    INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
    INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
    INJEX 30 NEEDLE FREE INJECTION SYSTEM
    BI-3M NEEDLE-FREE INJECTOR SYSTEM
    JET SYRINGE MODEL-100500
    SEROJET
    INJEX 50 SYSTEM
    CLICKER
    MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
    J-TIP NEEDLESS INJECTOR
    J-TIP INJECTOR
    BIOJECTOR 2000 MODEL 1B02000
    VITAJET
    MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
    MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC
    MEDIVAX
    HYPEX(TM) JET INJECTOR
    BIOJECT JET INJECTION SYSTEM
    PRECI-JET 50
    OPHTHALMIC VISCOINJECTOR DRIVE
    MED-E-JET INJECTOR
    INJECTOR, INSULIN
    VITAJET(INSULIN JET INJECTION DEVICE)
    J-TIP INJECTOR SYSTEM
    DERATA MEDI-JECTOR V
    ROBINJECT
    BIOJECTOR SYRINGE SYSTEM
    DERATA MEDI-JECTOR IV
    INJET-100, FLUID INJECTOR
    JECT-AID
    MEDAJET XL - JET INJECTOR
    DERATA MEDI-JECTOR PRO
    VACUUM COMPRESSION INJECTOR
    PRECI-JET 50
    NEW VITAJET
    DERATA MEDI-JECTOR III

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump