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.
Catheter, Neurovasculature, Occluding Balloon
Neurology
The Neurovasculature Occluding Balloon Catheter is a device used for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage that has been secured by surgical or endovascular intervention, in patients who have failed maximal medical management. The FDA called for PMAs for this device category following the Federal Register notice at 61 FR 50708 on September 27, 1996. As an FDA Class 3 device regulated under 21 CFR 882.5150 in the Neurology specialty, it requires Premarket Approval (PMA). The product code is NUF, and this device is flagged as life-sustaining given its use in critical neurovascular treatment.
No 510(k) clearances found for "NUF". 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.