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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Toilet Seat Sanitizer
Unknown
The Toilet Seat Sanitizer is an ultraviolet wavelength noncoherent light source used to sanitize toilet seats in commercial or public restroom settings. It is classified as FDA Not Classified (Class N) with product code RGH and is GMP-exempt. This product has no associated regulation number or medical specialty, reflecting its use as a hygiene and sanitation device rather than a medical product. No implant or life-sustaining flags are noted. FDA oversight applies under electronic product radiation control provisions for UV light-emitting devices.
No 510(k) clearances found for "RGH". 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.