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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Intracranial Neurovascular Stent
Unknown
The Intracranial Neurovascular Stent is a tubular implantable device placed in the blood vessels of the intracranial cavity to treat vascular abnormalities such as cerebral aneurysms, distinguishing itself from other stents by its specific indication for intracranial use. This device has a device class of "f" (not classifiable under a standard classification) and is subject to FDA's premarket approval or de novo process (submission type 6), under product code NJE in the Neurology review panel (no regulation number assigned). The device is flagged as an implant but is not life-sustaining.
No 510(k) clearances found for "NJE". Try a different K-number, product code, or device name.
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.