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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Percutaneous Catheter, Ultrasound
Cardiovascular
The Percutaneous Catheter, Ultrasound is a cardiovascular catheter intended for ultrasound wave-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature. It is classified as FDA Class 2 under 21 CFR 870.1250, requiring a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device is used in the Cardiovascular specialty to treat peripheral arterial disease through a minimally invasive approach. Product code PPN; not an implant and not life-sustaining.
510(k) Clearances
12 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.