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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: HBL FDA class 2

    Holder, Head, Neurosurgical (Skull Clamp)

    Neurology

    View full classification →

    The Neurosurgical Head Holder (Skull Clamp) is a rigid fixation device used to immobilize the patient's head in a precise, stable position during intracranial surgical procedures, allowing the surgeon to operate without risk of inadvertent head movement. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBL under regulation 21 CFR 882.4460 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
    DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
    DORO QR3 Headrest System (Aluminum)
    DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
    DORO LUCENT® iXI and iMRI Headrest System
    Arcus Head Fixation Frame
    DORO QR3 XTom Headholder System
    TZ SKULL PIN Adult
    MAYFIELD Skull Clamp
    HFD100 ROCKER ARM ACCESSORY
    STERILE RADIOLUCENT SKULL PINS
    MAYFIELD INFINITY XR2 SKULL CLAMP
    MAYFIELD SKULL CLAMP
    IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
    HEAD FIATION DEVICE (HFD 100)
    FIXIT HEADREST CLAMP SYSTEM
    HEAD FIXATION ARC AND TABLE BASE
    DINKLER SURGICAL SKULL CLAMP, MODEL 0308
    MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
    MAYFIELD MR/X-RAY SKULL CLAMP
    LIMITED ARTIFACT SKULL PIN, MODEL 0107
    MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
    MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
    DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
    MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
    MAYFIELD INFINITY SKULL CLAMP
    MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
    DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
    MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
    VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
    PSI SKULL CLAMP
    DORO HEADREST SYSTEM
    MIZUHO RADIOLUCENT HEAD FRAME
    MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
    MAYFIELD CHILD DISPOSABLE SKULL PIN
    MAYFIELD RADIOLUCENT SKULL CLAMP
    MAYFIELD ADULT DISPOSABLE SKULL PIN
    MAYFIELD* A-2000 SKULL CLAMP
    MAYFIELD ADULT DISPOSABLE SKULL PIN
    CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
    CODMAN DISPOSABLE SKULL PINS
    CODMAN SKULL CLAMP
    GARDNER PINS (ADULT & CHILD)
    CODMAN SKULL CLAMP
    MAINZ HEAD FIXATION BY PERNECZKY
    MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM
    MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME
    SURGITA/MIZHO MICRONEUROSURGERY HEAD FR

    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.

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