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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Clinical Chemistry
An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically and continuously or frequently measure glucose in bodily fluids for managing glycemic control, transmitting data to digitally connected devices including automated insulin dosing systems; the dexamethasone acetate coating is specifically included to reduce inflammation at the sensor insertion site. It is classified as FDA Class II (510(k) required) under regulation 862.1357 in the Clinical Chemistry specialty, with product code SBA. The device is flagged as an implant due to the subcutaneous sensor, but does not support life-sustaining functions.
510(k) Clearances
2 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.