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.
Leeches, Medicinal
Unknown
Medicinal Leeches (Hirudo medicinalis) are aquatic, bloodsucking annelid worms used as an adjunct to graft tissue healing, particularly to overcome venous congestion by creating prolonged localized bleeding. They are indicated when venous congestion may delay healing following surgical procedures. This device is currently unclassified (Class U) by the FDA, and regulatory responsibility has been transferred from CDRH to the Center for Biologics Evaluation and Research (CBER) per Federal Register Notice at 89 FR 106521. The product code is NRN, reviewed by the General Surgery panel, and the unclassified reason is coded as 1.
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.