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.
Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
General, Plastic Surgery
The software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer (product code QZS) is a Class 2 General, Plastic Surgery prescription device (regulation 878.1830) that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a lesion classification. Requiring 510(k) clearance, it is intended for use by physicians not trained in clinical diagnosis and management of skin cancer as a second-read adjunctive device following identification of a suspicious lesion, and is not intended as a standalone diagnostic or to confirm a clinical diagnosis. It is not an implant and is not life-sustaining.
510(k) Clearances
1 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.