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.
Materials, Repair Or Replacement, Pacemaker
Cardiovascular
Pacemaker Repair or Replacement Materials are components and materials used to repair or replace parts of implanted cardiac pacemakers, intended to restore or maintain the function of a pacemaker system already in situ in a patient. It is classified as FDA Class 3, the highest risk category, reflecting the critical nature of cardiac pacing support; devices in this class require Premarket Approval (PMA), demonstrating a reasonable assurance of safety and effectiveness through clinical evidence. The product code is KFJ, regulated under 21 CFR 870.3710, within the Cardiovascular medical specialty. This device is an implant.
510(k) Clearances
3 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.