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: NUC FDA class 2

    Lubricant, Personal

    Obstetrics/Gynecology

    View full classification →

    The Personal Lubricant is a device intended for penile and/or vaginal application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. The product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. It is an FDA Class 2 device regulated under 21 CFR 884.5300 in the Obstetrics/Gynecology specialty, with product code NUC, requiring 510(k) clearance. Third-party review is available. It does not carry implant or life-sustaining support designations.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
    Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
    pjur NATURE Touch, 100 ml
    Julva Velvé Water-Based Personal Lubricant
    Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
    Water-based lubricant
    Chiavaye Personal Moisturizer
    Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
    Cerynë Intimate Care
    Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
    Water-based Lubricant
    Plain Water-based Lubricant
    LubriZenzs
    Water Solubility Human Body Lubricant
    Sutil Rich Personal Lubricant
    Joylux Intimacy Gel (PG3100)
    Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)
    INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
    ID Free Personal Lubricant
    Coconut Hybrid
    Human Lubricant
    Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
    Gynatrof
    Elegant™ Advanced CompHort
    Woo More Play Coconut Love Oil
    JO Coconut Hybrid Cooling Personal Lubricant
    JO Coconut Hybrid Warming Personal Lubricant
    Carex Hybrid Personal Lubricant
    Play and Joy Water-Based Lubricant
    Play&Joy InvisiLube Lubricant Capsule
    HydraDose Vaginal Suppositories
    Belle Sensilube
    JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
    X-Y Lubricating Jelly
    Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
    Playground For All Love Sesh
    Bloomi Delight Oil-Based Personal Lubricant
    Onetouch Non-paraben Lubricant Gel
    OFNat Lubricant (L15)
    Wet Flavored Personal Lubricants
    JO CUMPLAY Personal Lubricant
    Bloomi Smooth Water Based Lubricant
    Wet Essential95 Personal Lubricant
    Astroglide Warming
    Revaree Plus Vaginal Suppositories
    Astroglide Ultra Gentle Gel
    Astroglide Glycerin & Paraben Free
    Sensuva Premium Silicone Personal Lubricant
    Astroglide Sensual Strawberry Personal Lubricant
    Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry

    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