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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Temporary Non-Roller Type Right Heart Support Blood Pump
Cardiovascular
The Temporary Non-Roller Type Right Heart Support Blood Pump is a device intended to provide temporary partial or full right heart circulatory support in patients with acute right heart failure. It is classified as a Class 3 device under regulation 870.4360, the highest risk category requiring Premarket Approval (PMA) due to its critical cardiovascular support function. The product code is PYX, and it falls within the Cardiovascular (CV) medical specialty. It is flagged as life-sustaining, reflecting the critical nature of its circulatory support role.
No 510(k) clearances found for "PYX". 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.