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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Right Ventricular Bypass (Assist) Device
Unknown
The Right Ventricular Bypass (Assist) Device is a cardiovascular device intended to provide circulatory support for patients experiencing cardiogenic shock due to acute right ventricular failure, temporarily taking over the pumping function of the right ventricle. It carries a device class designation of "f," indicating it is regulated under a Humanitarian Device Exemption (HDE) pathway for rare conditions, reviewed by the Cardiovascular panel; no regulation number has been assigned. The product code is OJE. It is not flagged as an implant or life-sustaining device in the classification record.
No 510(k) clearances found for "OJE". 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.