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.
First Aid Kit With Drug
Unknown
The First Aid Kit with Drug is a convenience kit containing both medical device components and drug products intended for first aid use; in addition to compliance with the FDA convenience kit guidance, any drug products contained in this kit are subject to applicable drug regulatory requirements. This product's device class is designated as "N," indicating it is not a medical device under FDA's device classification framework, or the classification status is not applicable in the standard sense. The product code is LRR; no regulation number or medical specialty is listed. No special flags apply to this product.
510(k) Clearances
15 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.