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.
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cardiovascular
An Implantable Cardiac Event Recorder Without Arrhythmia Detection is a small device surgically implanted subcutaneously that continuously records the patient's electrocardiogram over months to years, used to capture and store cardiac rhythm data during symptomatic episodes for later physician review, without automated arrhythmia detection algorithms. It is FDA Class 2, requiring 510(k) clearance, is an implant, with product code MXC under 21 CFR 870.2800 in the Cardiovascular specialty. The device is not life-sustaining.
510(k) Clearances
23 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.