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.
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Clinical Chemistry
The Integrated Continuous Glucose Monitoring System, Factory Calibrated (iCGM) is an automatic glucose monitoring device intended to measure glucose in bodily fluids continuously or frequently, designed to reliably and securely transmit glucose data to digitally connected devices including automated insulin dosing (closed-loop) systems, for use alone or in conjunction with these devices in managing glycemic control. It is classified as a Class 2 device under regulation 862.1355, requiring 510(k) premarket notification, and falls within the Clinical Chemistry (CH) medical specialty. The product code is QBJ. It is not an implant and is not life-sustaining.
510(k) Clearances
15 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.