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.
Dilator, Nasal
Ear, Nose, Throat
The Nasal Dilator (product code LWF) is a small device placed in or around the nasal passage to mechanically widen the nasal airway, aiding in breathing during sleep, exercise, or in cases of nasal congestion or obstruction. Regulated under 21 CFR 874.3900 and classified as a Class 1 device subject only to general controls, it falls under the Ear, Nose, and Throat medical specialty. The device is not exempt from GMP requirements. It is not an implant and is not life-sustaining.
510(k) Clearances
20 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.