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.
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
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The Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE) is an interventional cardiology catheter used in catheter ablation procedures to treat atrial fibrillation by delivering energy to ablate tissue responsible for the initiation or maintenance of the arrhythmia. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Cardiovascular panel. This device carries a life-sustaining flag given its role in treating a serious and potentially debilitating cardiac arrhythmia.
No 510(k) clearances found for "OAE". 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.