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.
Controller, Temperature, Cardiopulmonary Bypass
Cardiovascular
The Cardiopulmonary Bypass Temperature Controller is a life-sustaining cardiovascular device used to regulate the temperature of water or blood within the heat-exchange system of an extracorporeal circuit, controlling patient body temperature during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWC and it is regulated under 21 CFR 870.4250 within the Cardiovascular medical specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission (82 FR 26807). This device is designated as life-sustaining or life-supporting.
510(k) Clearances
30 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.