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.
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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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Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
Radiology
The Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox is a radiology device intended to present images reflecting magnetic resonance spectra for the determination of liver iron concentration, used as a companion diagnostic to guide treatment with the iron chelator deferasirox. It falls under the Radiology medical specialty and is classified as a Class 2 device under regulation 892.1001, requiring 510(k) premarket notification. This type of imaging aids in monitoring iron overload in patients with conditions such as thalassemia or sickle cell disease. It is not an implant and is not life-sustaining.
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.