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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Agent, Occluding, Vascular, Permanent
Unknown
The Permanent Vascular Occluding Agent is a polymerizing agent device intended for the permanent occlusion of peripheral blood vessels, used in interventional radiology and vascular surgery to block abnormal or unwanted blood flow. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the permanent and irreversible nature of vascular occlusion, reviewed by the Cardiovascular (CV) panel. The product code is PJQ, and it is flagged as an implant. No regulation number or medical specialty has been formally assigned.
No 510(k) clearances found for "PJQ". 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.