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.
Let the assistant find your predicates
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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Coronary Covered Stent
Unknown
The Coronary Covered Stent is a metal scaffold covered with a biocompatible material, placed via catheter into the coronary artery or saphenous vein graft to treat free perforations and/or to prevent dislodgement of biological material from the vascular wall during or following device placement. This device has a device class of "f" (unclassifiable under a standard classification) and is subject to FDA's premarket approval or de novo process (submission type 6), under product code NIV in the Cardiovascular review panel (no regulation number assigned). The device is flagged as both an implant and life-sustaining/life-supporting.
No 510(k) clearances found for "NIV". 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.