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.
Reprocessed Bronchoscope
Ear, Nose, Throat
The Reprocessed Bronchoscope is a reprocessed single-use bronchoscope used for visualization and procedures within the airways and bronchi, equivalent to the original EOQ bronchoscope classification except that it has undergone reprocessing. Reprocessing validation data must be included in any 510(k) submission for this device type. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 874.4680 in the Ear, Nose, Throat specialty. It carries product code QNW and is not an implant and not life-sustaining.
510(k) Clearances
2 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.