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.
Phages, Staphylococcal Typing, All Types
Microbiology
The Phages, Staphylococcal Typing, All Types is a set of bacteriophage preparations used in reference laboratory phage-typing methods to epidemiologically classify Staphylococcus aureus isolates into phage types, an important tool for outbreak investigation. It is an FDA Class 1 device, subject only to general controls and requiring no premarket submission. The product code is GTL, regulated under 21 CFR 866.2050 in the Microbiology specialty. No special flags apply to this device.
No 510(k) clearances found for "GTL". 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.