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.
Video Monitor, Medical Imaging, Monochrome
Unknown
The Video Monitor, Medical Imaging, Monochrome (product code RBF) is an electronic product that uses a monochrome cathode ray tube to display medical images in black and white, shades of gray, or different shades of one color from signals generated by a computer or electronic medical device. This product is FDA not classified and is regulated under electronic product radiation control authority. It is GMP exempt with no associated regulation number, medical specialty, implant flag, or life-sustaining designation.
No 510(k) clearances found for "RBF". 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.