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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Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
Unknown
The Generator, Measurement, and/or Delivery System for Hyperpolarized MR Imaging Agents and Accessories is a device system used to generate hyperpolarized MR imaging agents at the point of care, monitor the volume of dispensed doses, and/or store, transport, or administer the imaging agent to patients undergoing hyperpolarized MRI examinations. This device carries a status of "not classified," as it is regulated primarily in conjunction with CDER- or CBER-led drug or biologic products and falls outside standard device classification pathways. It is reviewed under the Radiology panel and is not an implant or life-sustaining.
No 510(k) clearances found for "QVW". 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.