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.
Single Lumen Ecmo Cannula
Cardiovascular
The Single Lumen ECMO Cannula is a cardiovascular device consisting of single-lumen cannulas or catheters intended for use with extracorporeal circuits in patients with acute respiratory failure or acute cardiopulmonary failure where other treatments have failed and the risk of death is imminent. It is classified as FDA Class 2, requiring 510(k) clearance, and falls under the Cardiovascular medical specialty, regulated under 21 CFR 870.4100. The product code is QHW. Despite its critical application in life-threatening situations, the device is not formally flagged as life-sustaining in this classification record, and it is not an implant.
510(k) Clearances
2 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.