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: HHT FDA class 2

    Spatula, Cervical, Cytological

    Obstetrics/Gynecology

    View full classification →

    The Cytological Cervical Spatula is a sampling instrument used to scrape cells from the transformation zone of the cervix for cytological examination, most commonly as part of a Pap smear screening procedure for cervical cancer or precancerous conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHT, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    exCellerator Cervical Collection Device
    Kolplast Cervical Sample Collection Kit
    DISPOSABLE CERVICAL BRUSH
    HISTOBRUSH
    PAPCONE
    BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
    SOFTPAP CERVICAL CELL COLLECTOR
    DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
    CERVEX-BRUSH COMBI
    SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    DRG SOFTRELEASE
    INPATH E2 COLLECTOR
    ROVERS SPATULA
    ROVERS ENDOCERVEX-BRUSH
    ORIBRUSH - WITH PROTECTIVE TIP - B001
    ORIBRUSH - STANDARD - B002
    HARWILL MEDICAL CERVITULA CERVICAL SPATULA
    SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
    SAFETEX CERVICAL SCRAPER (PLASTIC)
    CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
    DIGENE CERVICAL BRUSH
    CYTOLOGY BRUSH
    PAP BRUSH
    EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
    PURITAN FOAM TIP SWAB MODEL 2197
    DETECT CYTOLOGY BRUSH II
    GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
    AMSINO CERVICAL SCRAPER
    CERVEX-BRUSH PAP KIT
    VIBA-BRUSH
    PELVIC EXAM TRAY
    CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY
    CERVEX-BRUSH
    MICRO-PAP(TM) KIT
    CYTOLOGY BRUSH
    DETECT (TM) CYTOLOGY BRUSH
    EXACT-TOUCH
    ACCELLON CERVICAL BIOSAMPLER
    CYTO PAK PAP SMEAR KIT
    CELL COLLECTING BRUSH
    CELL SWEEP
    PC-BEADS POSTCOITAL TEST
    CYTETTE(TM) CYTOLOGY BRUSH
    CYTOSET(TM)
    SPATULA FOR PAP SMEAR COLLECTION
    WALLACH CC/BRUSH
    PAP SMEAR TRAY
    CERVEX-BRUSH
    CYTOBRUSH
    KOTEX SUPER MAXI PADS

    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