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.
Culture Media, Antimycobacteria, Susceptibility Test
Microbiology
Antimycobacterial Susceptibility Test Culture Media are laboratory culture media formulated to support the growth of Mycobacterium species and to enable determination of the minimum inhibitory concentrations of antimycobacterial drugs, providing critical data for guiding tuberculosis and nontuberculous mycobacterial therapy. Classified as a Class 2 device under 21 CFR 866.1700 in the Microbiology specialty, these media require 510(k) premarket notification. They carry no implant or life-sustaining flags.
510(k) Clearances
3 matchesWhat 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.