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.
Media, Reproductive, Exempt
Obstetrics/Gynecology
Media, Reproductive, Exempt is a Class 2 obstetrics and gynecology device that is the 510(k)-exempt counterpart of product code MQL, exempted under the 21st Century Cures Act, meaning it does not require premarket notification to market provided it does not exceed the general limitations of exemption under 21 CFR 884.9. It is regulated under 21 CFR 884.6180 within the Obstetrics/Gynecology medical specialty. The product code is QKI. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "QKI". 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.