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.
Percutaneously Delivered Prostheses And Tricuspid Valves
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The percutaneously delivered tricuspid valve prosthesis is a cardiovascular implant intended to replace a patient's diseased tricuspid heart valve using a minimally invasive percutaneous catheter-based approach, avoiding open-chest surgery or cardiotomy. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to the life-critical function of heart valve replacement. Product code NPW carries both implant and life-sustaining flags and is reviewed by the Cardiovascular panel.
No 510(k) clearances found for "NPW". 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.