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.
Injection Data Capture Device
General Hospital
The Injection Data Capture Device is an electrically-powered or electromechanical accessory that interfaces with reusable or disposable injection devices to interpret, record, display, and/or transmit injection data to a connected application or software platform. It is used to improve adherence monitoring and injection logging in clinical or patient self-care settings. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5860 in the General Hospital specialty. It carries product code QOG and is not an implant and not life-sustaining.
510(k) Clearances
7 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.