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: NDC FDA class 2

    Calculator, Drug Dose

    Anesthesiology

    View full classification →

    The Calculator, Drug Dose (product code NDC) is an anesthesiology device used to assist clinicians in calculating appropriate drug dosages for patients. It is classified as an FDA Class 2 device, requiring 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. No specific regulation number has been assigned to this product code. The device falls within the Anesthesiology specialty and is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EndoTool IV (3.1)
    InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
    iSage Rx
    Insulia Bolus Companion
    BlueStar and BlueStar Rx
    Digital Routines
    EndoTool SubQ 2.1
    BlueStar Rx
    Insulia Diabetes Management Companion
    EndoTool IV System
    InPen System
    EndoTool IV 1.10
    InPen Dose Calculator
    InPen System
    d-Nav System
    EndoTool SubQ
    InPen Dose Calculator
    Glooko Mobile Insulin Dosing System
    Insulia Diabetes Management Companion
    Health-e-Connect System with IDA
    Glucommander
    Insulia Diabetes Management Companion
    Insulin Algorithms System
    My Dose Coach
    My Dose Coach
    iSage Rx (iSage Rx Basal Insulin Titration)
    Go Dose System
    Insulia Diabetes Management Companion
    ACCU-CHEK Connect Diabetes Management App
    EndoTool SubQ
    ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
    REACH ACCESS TELEMEDICINE DOSE CALCULATOR
    GLUCOSTABILIZER INSULIN DOSING CALCULATOR
    ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
    PICIS WEIGHT BASED DOSE CONVERTER
    G+ SYSTEM
    G+ SYSTEM
    INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
    GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
    CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
    ENDOTOOL DRUG DOSE CALCULATOR
    GLUCOMMANDER PLUS
    ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
    TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
    PDT DOSECALCULATOR, MODEL 80000
    DC-1 I.V. DOSAGE COMPUTER
    DIACARE MONITORING SYSTEM
    PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
    COMPUTER ASSISTED DIABETIC INTRUCTION
    ABBOTT PHARAMACOKINETICS SYSTEMS

    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