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: KPE FDA class 2

    Container, I.V.

    General Hospital

    View full classification →

    This device is an intravenous (I.V.) container used to hold and deliver fluids, medications, or parenteral nutrition to patients via intravenous infusion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPE, regulated under 21 CFR 880.5025 within the General Hospital specialty. This device is eligible for third-party review as part of the 510(k) process.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
    eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
    eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
    Disposable Infusion Bag for Parenteral Nutrition
    Empty EVA Bag
    SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
    Empty EVA Bag
    HCT Empty EVA Container Pack
    Additive Cap
    Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
    STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
    EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
    ADDITIVE CAP
    EVA TPN BAG
    ALL-IN-ONE CONTAINER
    DUAL CHAMBER TPN CONTAINER
    KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
    CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
    EVA TPN CONTAINER
    GRI-BAG, GRI-BAG AP
    GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
    EVA EMPTY SOLUTION CONTAINER
    ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
    TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
    EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
    ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
    MPS RESERVOIR BAG
    STERI-TAMP
    CHARTERMED TPN-EVA BAGS
    VITALMIX PLUS EMPTY I.V. CONTAINER
    INTRAVIA CONTAINER, EMPTY
    SECURE EVA DUAL CHAMBER MIXING BAG
    ALL-IN-ONE TWO CHAMBER CONTAINER
    EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
    UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
    DISPOSABLE BAG DECANTER
    SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)
    PHARMAFEED
    EVA EMPTY MIXING CONTAINER
    EMPTY MIXING CONTAINER
    DUAL CHAMBER MIXING BAG
    EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG
    EMPTY VIAFLEX PLASTIC CONTAINER
    SNAPPER
    DUAL COMPARTMENT TPN BAG 3 LITER
    EMPTY I.V. CONTAINER
    CHEMOTHERAPY CONTAINER
    BAG SPIGOT
    ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION
    CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY

    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