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
Generator, Pulsatile Flow, Cardiopulmonary Bypass
Cardiovascular
The Generator, Pulsatile Flow, Cardiopulmonary Bypass is a high-risk cardiovascular device used during open-heart surgery to generate pulsatile blood flow within the cardiopulmonary bypass circuit, mimicking the natural pulsatile output of the heart and supporting organ perfusion during cardiac procedures. As described in the regulatory definition, a PMA or notice of completion of a Product Development Protocol (PDP) is required; any device in commercial distribution before May 28, 1976, or found substantially equivalent to such devices required a filed PMA or completed PDP by September 21, 2004, and any other device must have an approved PMA or declared completed PDP before commercial distribution. This device is FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) demonstrating safety and effectiveness. It carries product code JOR and is regulated under 21 CFR 870.4320, within the Cardiovascular medical specialty.
No 510(k) clearances found for "JOR". 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.