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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.

    Let the assistant find your predicates

    Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples
    Product Code: KDD FDA class 1

    Kit, Surgical Instrument, Disposable

    General, Plastic Surgery

    View full classification →

    A disposable surgical instrument kit is a pre-assembled, single-use collection of surgical tools packaged together for a specific procedure or general surgical use, intended to reduce processing time and eliminate the risk of cross-contamination associated with reusable instruments. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KDD is regulated under 21 CFR 878.4800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
    INSTRUMENTS FOR ONE TIME USE - DISPOSABLE
    NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
    DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
    CUSTOM CV PACK
    SUTURE SET OR LACERATION TRAYS (PACKS)
    SURGICAL INSTRUMENT KIT, DISPOSABLE
    KIT, SURGICAL INSTRUMENT, DISPOSABLE
    BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY
    STERILE SURGICAL INSTRUMENT TRAYS
    DEXIDE LAPAROSCOPIC KITS
    SURGICAL INSTRUMENT KIT, DISPOSABLE
    LACERATTION TRAY
    GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
    STERILE CUSTOM SURGICAL KITS
    SLIP-PRUF-CLINGER
    BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
    IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE
    INCISION AND DRAINAGE KIT
    MEGA GENERAL PURPOSE INSTRUMENT KIT
    DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
    SKILCRAFT
    ENTERON ABDOMINAL PARACENTESIS TRAY
    SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
    STERILE PROCEDURAL TRAYS
    JMS HALO APPLICATION TRAY
    SUTURE REMOVAL KIT
    COOK COUNTY HOSPITAL DRESSING CHANGE SET
    STERILE SUTURE REMOVAL KIT
    C-SECTION TRAY
    STERILE SOLUTION BOWL
    STERILE SUTURE BOOTS
    PREPACELL-STERILE-BONE MARROW ASPIR
    VYGON THORACIC DRAINAGE-VARIOUS #'S
    WET DRESSING KIT
    STERILE WET DRESSING PACK
    STERILE DISP. INSTRUMENT TRAYS
    STERILE SUTURE REMOVAL SET
    FIRST AID KITS
    RESCUE PACK
    OPEN HEART TRAY (CUSTOM DESIGNED)
    STERILE SUTURE REMOVAL KIT
    HEMO-NATE L-P KIT
    STERILE CATH CARE KIT
    STERILE TRACHEOSTOMY CARE KIT
    SUTURE REMOVAL TRAY
    ACKRAD INCISION & DRAIN SET
    SKIN SCRUB KITS
    SUTURE REMOVAL SET(DISPLSABLE)
    SUTURE REMOVAL KIT

    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
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