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.
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Kit, Chemical Snake-Bite
General Hospital
The Chemical Snake-Bite Kit is a device used in emergency response to snake envenomation, employing chemical agents rather than purely mechanical means in the treatment or neutralization of snake bite injury. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness; PMAs were required to be filed by December 26, 1996, per 61 FR 50708 on September 27, 1996. The product code is KYQ, regulated under 21 CFR 880.5760, in the General Hospital medical specialty. No special flags apply to this device.
No 510(k) clearances found for "KYQ". 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.