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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Cleanser, Denture, Prescription
Dental
The Prescription Denture Cleanser is an effervescent tablet intended for the removal of microorganisms from removable dentures and retainers, used to maintain oral hygiene and prosthesis hygiene. Unlike over-the-counter cleansers, this prescription formulation may contain more active antimicrobial components. It is an FDA Class 1 device regulated under 21 CFR 872.3520 in the Dental specialty, with product code NUX, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
No 510(k) clearances found for "NUX". 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.