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, Implanted, Adjunctive Use
Unknown
The Continuous Glucose Monitor, Implanted, Adjunctive Use is a fully implanted device intended to detect trends and track patterns in interstitial glucose values as an adjunct to complement, not replace, information from standard home blood glucose monitoring devices. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risks associated with fully implanted continuous monitoring in diabetic patients. The product code is QCD with no assigned regulation number, reviewed by the Clinical Chemistry panel. This device carries an implant flag.
No 510(k) clearances found for "QCD". Try a different K-number, product code, or device name.
What 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.