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, (With Arrhythmia Detection)
Cardiovascular
The Implantable Cardiac Event Recorder with Arrhythmia Detection is a subcutaneously implanted monitoring device designed to continuously record cardiac electrical activity and automatically detect arrhythmias. It is used for long-term cardiac monitoring in patients with infrequent or unexplained symptoms such as syncope or palpitations that are difficult to capture with standard ambulatory monitors. Classified as FDA Class 2, it requires 510(k) premarket notification under regulation 870.1025 (Cardiovascular specialty). This device carries an implant flag, reflecting its implanted nature and the associated clinical considerations for patient safety.
510(k) Clearances
29 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.