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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: FRN FDA class 2

    Pump, Infusion

    General Hospital

    View full classification →

    An infusion pump is a device used to deliver controlled volumes of fluids, medications, or nutrients directly into a patient's circulatory system over a defined period of time. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is FRN, regulated under 21 CFR 880.5725, within the General Hospital medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MRidium 3870 MRI Infusion Pump System (3870)
    BD Alaris Infusion System with Guardrails Suite MX
    Plum Duo™ Precision IV Pump
    Plum Solo™ Precision IV Pump
    RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
    Remunity 2.0 Pump for Remodulin (treprostinil) Injection
    Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
    Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
    Novum IQ Syringe Pump (40800BAXUS)
    Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
    Novum IQ Large Volume Pump
    Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
    SAFIRA
    Plum Duo™ Infusion System
    BD Alaris System with Guardrails Suite MX v12.1.2
    Spectrum IQ Infusion System with Dose IQ Safety Software
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
    Avoset Infusion Pump System
    Spectrum IQ Infusion System with Dose IQ Safety Software
    Novum IQ Syringe Pump
    Spectrum IQ Infusion System with Dose IQ Safety Software
    FreedomEdge Syringe Infusion System
    Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable
    Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo
    FREEDOM Integrated Syringe Infusion System
    FreedomEdge(R) Syringe Infusion System
    Sapphire Infusion Pump, Sapphire administration sets
    Ivenix Infusion System (IIS)
    Unity Subcutaneous Delivery System for Remodulin
    Power Infuser
    Perfusor® Space Syringe Infusion Pump System
    Spectrum IQ Infusion System, Dose IQ Safety Software
    Integrated Catch-up Freedom Syringe Driver Infusion System
    Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
    Sapphire Infusion Pump
    MRidium 3860+ MRI infusion Pump/ Monitoring System
    Concert Medical Hands-Free Syringe (HFS)
    Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
    Navigator Aesthetic Delivery System
    Infusomat Space Volumetric Infusion Pump
    PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
    SAPPHIRE INFUSION PUMP
    HALO AMBULATORY INFUSION SYSTEM
    ALARIS SYSTEM WITH GUARDRAILS SUITE MX
    THE BELMONT RAPID INFUSER
    HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
    BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
    SAPPHIRE INFUSION PUMP
    KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
    Z-800 INFUSION SYSTEM

    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

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