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.
System, Transdermal Delivery, Cder Or Cber Led
Unknown
The Transdermal Delivery System (CDER or CBER Led) is a drug-device combination product consisting of a system designed to deliver at least one therapeutically active ingredient across the skin for systemic effect. It is classified as Not Classified (Class N), reviewed by the General Hospital panel, with no regulation number assigned; it is unclassified because its primary mode of action is attributable to a drug component regulated by CDER or CBER. The product code is QIX. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "QIX". 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.