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.
Test, Urea Adult And Pediatric (Breath),
Microbiology
The Test, Urea Adult and Pediatric (Breath) is an in vitro diagnostic device intended for the qualitative detection of urease associated with Helicobacter pylori in the human stomach, indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults and pediatric patients, with use for monitoring treatment at 4 weeks following completion of therapy. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA), with product code OZA and regulation number 866.3110 under the Microbiology medical specialty.
No 510(k) clearances found for "OZA". 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.