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.
Programmer, Pacemaker
Cardiovascular
This device is a pacemaker programmer, an external device used by clinicians to non-invasively communicate with and adjust the operational parameters of an implanted cardiac pacemaker, such as pacing rate, output, and sensitivity. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to the potential for the device to adversely affect the function of the life-sustaining implanted pacemaker. The product code is KRG, regulated under 21 CFR 870.3700 within the Cardiovascular specialty. No special flags such as implant or life-sustaining designations are recorded for this entry.
510(k) Clearances
25 matchesWhat 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.