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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: FLL FDA class 2

    Continuous Measurement Thermometer

    General Hospital

    View full classification →

    A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification under this product code, which represents non-exempt devices as established by 90 FR 25889. The product code is FLL, regulated under 21 CFR 880.2910 in the General Hospital specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
    Infrared Thermometer
    AION TempShield™
    Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209)
    Wearable Digital Thermometer (T31)
    FMT Disposable and Autoclavable Temperature Probes
    Aulisa Temperature Module (TM0002)
    Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
    SteadyTemp
    Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
    Medical electronic thermometer (FC01, FC02)
    Wireless Smart Thermometer
    Digital Thermometer
    Probe Covers (YF-001, YF-002)
    Infrared Thermometer: Model YJ600
    VitalDetect
    Digital Thermometer, Model T28, T28L
    Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383
    THERMOCLICK
    Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)
    Reusable Temperature Probe, Disposable Temperature Probe
    Celsi Monitor
    iTEMPSHIELD
    Infrared Thermometer, Model: IR8807
    FMT Reusable Temperature Probes
    e-Celsius Medical System
    NC° Thermometer (Gen 3), Model Number: NCTG3
    Infrared Thermometer
    CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
    Digital Thermometer (Model QT001)
    Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
    Infrared Thermometer TET-351
    Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
    Digital Thermometer, Model: DT007, DT008
    Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
    Infrared Thermometer (Model: Y20001, Y20002)
    Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
    Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
    Infrared thermometer
    Infrared Forehead Thermometer
    Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
    Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
    Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
    Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
    Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
    Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
    Digital thermometer, Model DT101, DT102
    Infrared Thermometer (model: E201)

    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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