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.
Sensor, Glucose, Implanted, Non-Adjunctive Use
Unknown
The Sensor, Glucose, Implanted, Non-Adjunctive Use is an implanted glucose sensor intended to determine glucose levels and the direction and rate of change in people with diabetes, and is specifically indicated to replace information obtained from standard blood glucose monitoring devices for making treatment decisions. It also provides historical glucose data to facilitate long-term therapy adjustments. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA), reviewed by the Clinical Chemistry panel. The product code is QHJ, with no regulation number assigned, and the device carries an implant flag, indicating it is surgically placed within the body.
No 510(k) clearances found for "QHJ". 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.