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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Prosthesis, Penis, Inflatable
Gastroenterology, Urology
An inflatable penile prosthesis is a surgically implanted hydraulic device used to treat erectile dysfunction by allowing a patient to manually inflate implanted cylinders in the penis to achieve an erection, used when other therapies have failed. It is classified as FDA Class 3, the highest risk category, and requires Premarket Approval (PMA) demonstrating safety and effectiveness before marketing; PMAs were required to be filed by July 11, 2000, per 65 FR 19658. The product code is JCW, regulated under 21 CFR 876.3350, within the Gastroenterology and Urology medical specialty. This device is an implant.
No 510(k) clearances found for "JCW". 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.