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.
Computerized Cognitive Assessment Aid, Exempt
Neurology
The Computerized Cognitive Assessment Aid (Exempt) is a neurology device used to assist clinicians in assessing cognitive function, potentially aiding in the screening or monitoring of conditions such as dementia, traumatic brain injury, or other neurological disorders. Product code PTY is the Class II exempt counterpart of PKQ, exempted from the 510(k) requirement under the 21st Century Cures Act, subject to the limitations in 21 CFR 882.9. Under regulation 21 CFR 882.1470, it is a Class II device subject to general and special controls. It falls under the Neurology medical specialty and is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "PTY". 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.