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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: HBE FDA class 2

    Drills, Burrs, Trephines & Accessories (Simple, Powered)

    Neurology

    View full classification →

    Drills, Burrs, Trephines and Accessories (Simple, Powered) are powered neurosurgical cutting tools used to perforate and remove sections of the skull during craniotomy, craniectomy, or access procedures, with simpler mechanical configurations suited to straightforward bone cutting tasks. They are classified as Class 2 devices (moderate risk), requiring 510(k) premarket notification. The product code is HBE under regulation 21 CFR 882.4310 in the Neurology specialty. These devices are eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
    Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)
    iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
    Surgify Halo
    Hubly Electric Drill (H100)
    2.1 x 255mm Drill, 22mm Stop
    2.1 x 255mm Drill, 22mm Stop
    Twist Drills
    Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
    P300 Attachment
    ELAN 4 Electro Motor System
    Stryker iBur hubs and cutting accessories
    Velocity Alpha Highspeed Surgical Drill System
    ELAN 4 Tools
    Anspach Helix Dissection Tools
    Stryker MIS and Footed Attachments
    Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
    ELAN 4 Tools
    ELAN 4 Electro Motor System Tools
    POWEREASE System
    Cranial Drill Bits and Accessories
    OsteoMed PINNACLE Driver
    Phasor Drill
    DReal
    Stryker Footed Attachments and Cutting Accessories
    Stryker MIS Attachments and Cutting Accessories
    Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
    HICUT HIGHSPEED INSTRUMENT
    VARIOGUIDE DRILL KIT
    POWEREASE SYSTEM
    TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
    ANSPACH DISSECTION TOOLS
    IPC POWEREASE SYSTEM
    ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
    EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
    MIDAS REX CURVED BUR
    STRYKER TWIST DRILLS
    TWIST DRILL
    ANSPACH COUPLER
    ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
    ANSPACH ADVANCED MICRO SAW ATTACHMENTS
    STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
    SMALL HIGH SPEED MOTOR DRILL SYSTEM
    CRANIOCUT
    MICROAIRE 1000E SYSTEM
    ANSPACH ANGLED MICRONOSE ATTACHMENT
    XK-95 HIGH SPEED MOTOR DRILL SYSTEM
    75K STAIGHT DRILL
    MEDNEXT BUR
    CLINICAL NEURO SYSTEMS CRANIAL DRILL

    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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