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.
Contrast Media, Ultrasound
Unknown
Ultrasound Contrast Media are injectable agents, typically composed of gas-filled microbubbles, administered intravenously to enhance the echogenicity of blood and tissue during diagnostic ultrasound imaging, improving visualization of cardiac chambers, vascular structures, and organ perfusion. As a Class 3 device, it requires Premarket Approval (PMA) because its safety and effectiveness cannot be assured through general and special controls alone. No regulation number or specific medical specialty code is assigned, and it carries no implant or life-sustaining flags.
No 510(k) clearances found for "MJS". 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.