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.
Suntan Bed
General, Plastic Surgery
The Suntan Bed (product code REF) is a bed or other platform designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the human body with ultraviolet radiation at wavelengths between 200 and 400 nanometers in air, to induce skin tanning. It is a Class 2 device under FDA classification, requiring 510(k) premarket notification, regulated under 21 CFR 878.4635 under the General and Plastic Surgery medical specialty. It is not implantable, not life-sustaining, and is eligible for third-party 510(k) review.
No 510(k) clearances found for "REF". Try a different K-number, product code, or device name.
What 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.