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.
Percutaneous Atrial Catheter Kit
Cardiovascular
The Percutaneous Atrial Catheter Kit (product code OFK) is a cardiovascular convenience kit containing components for percutaneous placement of an atrial catheter, used in hemodynamic monitoring or cardiac procedures. Established under the May 1997 FDA Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) submission if all guidance criteria are met. This device is FDA Class 2 under regulation 870.1250 in the Cardiovascular specialty. It carries no implant or life-sustaining flags.
No 510(k) clearances found for "OFK". 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.