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.
Alternate Controller Enabled Insulin Infusion Pump
Clinical Chemistry
The Alternate Controller Enabled Insulin Infusion Pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient with basal and bolus drug delivery at set or variable rates, designed to reliably and securely communicate with external devices such as automated insulin dosing systems to allow insulin delivery commands to be received, executed, and confirmed. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 880.5730 in the Clinical Chemistry specialty. The product code is QFG. It is not an implant and is not life-sustaining.
510(k) Clearances
21 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.