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
Burn Kit With Drug
Unknown
The Burn Kit With Drug is a convenience kit containing components for the treatment of burn wounds, which includes an incorporated drug product as part of the kit. It carries an FDA device class designation of "N" (not classified/not a device) because the combination product's drug component changes its regulatory pathway; the kit is reviewed by the General, Plastic Surgery panel. It falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance. The product code is OJI. It is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "OJI". 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.