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.
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System And Accessories, Isolated Heart, Transport And Preservation
Gastroenterology, Urology
The Isolated Heart Transport and Preservation System and Accessories is a specialized device used to maintain a donor heart in a viable, isolated state during transport from the procurement site to the transplant center. It is classified as FDA Class 2, requiring a 510(k) premarket notification to demonstrate substantial equivalence prior to marketing. The product code is MSB, regulated under 21 CFR 876.5880, and falls under the Gastroenterology and Urology specialty panel. This device is not an implant and is not classified as life-sustaining.
510(k) Clearances
13 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.