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: DRC FDA class 2

    Trocar

    Cardiovascular

    View full classification →

    The Trocar is a cardiovascular surgical instrument with a pointed obturator used to puncture body walls or vessels, typically to create an access port for the introduction of catheters or other devices. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRC and it is regulated under 21 CFR 870.1390 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Accusafe Transseptal Guidewire (GTR31180, GTR31230)
    SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
    SafeSept® Transseptal Guidewire (SS-140)
    PathBuilder Transseptal Needle
    SafeSept Blunt Needle
    TSN Transseptal Needle
    Needle Free Transseptal Cannula
    SafeSept Needle Free Transseptal Guidewire
    SafeSept Transseptal Guidewire
    INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
    SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
    BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
    MOBICATH TRANSSEPTAL NEEDLE
    MOBICATH TRANSSEPTAL NEEDLE
    SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
    BRK TRANSSEPTAL NEEDLE
    HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
    MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
    VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
    TRANSSEPTAL NEEDLE/TROCAR
    INSTRUMENT DAMPING PORT
    INTERCOSTAL LOCKABLE-DIRECTABLE PORT
    MANAN POTTS-COURNAND NEEDLE
    MANAN
    MANAN GWI GUIDE WIRE INTRODUCER
    HEARTPORT THORACIC TROCAR
    HEARTPORT NEEDLE TROCAR
    GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
    MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
    ENDOSURG DISPOSABLE SECONDARY TROCAR
    ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
    R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
    DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
    LAPAROSCOPIC TROCAR
    SURGICAL TROCAR
    DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
    SELDINGER PERCUTANEOUS 2 PC NEEDLES
    SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)
    AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
    DISPOSABLE ANGIOGRAPHY NEEDLES
    NAMIC COURNAND STYLE INTRODUCER NEEDLE
    NAMIC ONE PART INTRODUCER NEEDLE
    NAMIC SELDINGER INTRODUCER NEEDLE
    MEDSURG POTT-COURNAND NEEDLE
    MEDSURG SELDINGER NEEDLE
    EMERSON TRO/CATH TROCAR CATHETERS
    STEIGER TUNNELING INSTRUMENT 285
    VISITEC NEEDLE RANGE (CARDIOVASCULAR)
    DILUTION KIT, THERMAL, COLD PAC
    NEEDLES USED IN ANGIOGRAPHIC PROCED.

    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