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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: LBI FDA class 2

    Unit, Neonatal Phototherapy

    General Hospital

    View full classification →

    A neonatal phototherapy unit is a medical device used in hospital settings to treat hyperbilirubinemia (jaundice) in newborns by emitting specific wavelengths of light that break down bilirubin in the skin. It is classified as FDA Class 2, requiring 510(k) premarket clearance to demonstrate substantial equivalence. The product code is LBI, regulated under 21 CFR 880.5700, in the General Hospital specialty. Third-party review eligibility applies.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BiliWrap
    Infant Phototherapy Equipment
    Neonatal Phototherapy System
    bili-hut
    neoBLUE blanket LED Phototherapy System
    BiliLux
    Skylife
    Bilicocoon™ Phototherapy System
    neoBLUE compact LED Phototherapy System
    Airborne Phototherapy Light
    neoBLUE® LED Phototherapy System
    BT-400
    INFANT PHOTOTHERAPY BILITRON SKY 5006
    GIRAFFE BLUE SPOT PT LITE
    LULLABY LED PHOTTHERAPY SYSTEM
    BILI-THERAPY PAD TYPE
    NANOBLUTM 500
    BRIGHT EMBRACE MODEL SBL60
    MEDILED MINI
    NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
    BILI-THERAPY SPOT TYPE
    BILI-MIRROR MODEL BLM-1
    BILI BLUE F20T12/BBY AND F40T12/BBY
    MEDILED PHOTOTHERAPY LAMP
    BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
    LULLABY
    WALLABY 4
    BILISOFT PHOTOTHERAPY SYSTEM
    NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
    NATUS BLUE LIGHT PHOTOTHERAPY UNIT
    RPI REPLACEMENT PHOTOTHERAPY LIGHTS
    OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
    CENTURA PHOTOTHERAPY SPOTLIGHT
    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
    WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
    PHOTOTHERAPY LAMP
    ULTRA BILI LIGHT
    DUO-LITE PHOTOTHERAPY SYSTEM
    OLYMPIC BILI-BASSINET
    BILIBED PHOTOTHERAPY LAMP
    DRAGER PT4000 PHOTOTHERAPY SYSTEM
    OLYMPIC BILI-LITE
    BILIBLANKET PLUS PHOTOTHERAPY SYSTEM
    MEDIX PHOTOTHERAPY LAMP
    BILIBLANKET LIGHT METER
    AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM
    OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
    OLYMPIC MINI BILI-LITE, MODEL 77
    OLYMPIC BILI-LITE-PAD(TM)

    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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