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.
Separator, Automated, Blood Cell And Plasma, Therapeutic
Unknown
Separator, Automated, Blood Cell and Plasma, Therapeutic is an automated apheresis device used to separate blood components such as red blood cells, platelets, or plasma from whole blood for therapeutic purposes, including therapeutic plasma exchange or red cell depletion in conditions such as sickle cell disease or hyperviscosity syndromes. This device is currently unclassified by the FDA, and its formal regulatory classification is pending. The product code is LKN; no regulation number or medical specialty has been assigned. The review panel is Gastroenterology/Urology.
510(k) Clearances
27 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.