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.
Cardiac Ablation Percutaneous Catheter
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The Cardiac Ablation Percutaneous Catheter is a device used to treat cardiac arrhythmias by delivering energy (such as radiofrequency energy) through a catheter advanced percutaneously to the heart to ablate abnormal electrical pathways. This product code pertains to cardiac ablation catheters indicated for general indications and for the treatment of supraventricular arrhythmias. It is classified as a Class 3 (highest risk) device, requiring Premarket Approval (PMA) prior to marketing. The product code is LPB; no specific regulation number or medical specialty code is recorded, though the review panel is Cardiovascular (CV). No special flags apply to this device.
No 510(k) clearances found for "LPB". 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.