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.
Vapocoolant Device
Unknown
The Vapocoolant Device is a topical spray or applicator that delivers a rapidly evaporating coolant, such as ethyl chloride or fluorocarbon, to the skin surface to produce a brief localized cooling effect used for temporary pain relief prior to minor procedures such as injections, venipuncture, or minor wound care. It is classified as Unclassified (Class U), indicating the FDA has not made a final classification determination, and no regulation number or medical specialty code is assigned. It carries no implant or life-sustaining flags.
510(k) Clearances
23 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.