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.
Wheelchair, Stair Climbing
Physical Medicine
A Stair Climbing Wheelchair is a powered wheelchair or mobility device specifically designed to ascend and descend stairs, enabling users with mobility impairments to independently navigate environments with stairways. As noted in the regulatory record, a PMA (Premarket Approval Application) was required to be filed by July 12, 2000, per 65 FR 19834. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification; however, this record indicates a PMA filing requirement, and manufacturers should consult current FDA guidance. The product code is IMK, regulated under 21 CFR 890.3890, within the Physical Medicine medical specialty.
510(k) Clearances
3 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.