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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Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Unknown
The Surgical Cardiac Ablation Device for Atrial Fibrillation (product code OCM) is a cardiovascular surgical device used to perform cardiac ablation for the treatment of atrial fibrillation, typically as part of open-heart or minimally invasive cardiac surgery. Ablation creates lesions in cardiac tissue to interrupt abnormal electrical pathways responsible for atrial fibrillation. This device is FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) given the critical nature of the cardiac application; it has no assigned regulation number or medical specialty code. It carries no implant or life-sustaining flags.
No 510(k) clearances found for "OCM". 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.