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.
Continuous Glucose Monitor Informed Insulin Dose Calculator
Clinical Chemistry
The Continuous Glucose Monitor Informed Insulin Dose Calculator is a software device that uses continuous glucose monitor (CGM) values and other relevant patient information to calculate suggested insulin doses for diabetes management. It is designed to assist patients and clinicians in making more precise and timely insulin dosing decisions. Classified as FDA Class 2 under regulation 862.1358, it requires 510(k) clearance in the Clinical Chemistry specialty. The device is not an implant and not life-sustaining.
510(k) Clearances
5 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.