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.
Intrasaccular Flow Disruption Device
Unknown
The Intrasaccular Flow Disruption Device (product code OPR) is a Class 3 neurovascular implantable device reviewed by the Neurology (NE) panel, requiring Premarket Approval (PMA) due to its high-risk indication. It is intended for the endovascular treatment of wide-neck intracranial aneurysms by being deployed within the aneurysm sac to disrupt blood flow and promote thrombosis, thereby reducing the risk of aneurysm rupture. The device is flagged as an implant and is not life-sustaining, and no regulation number has been assigned.
No 510(k) clearances found for "OPR". 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.