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.
Intravenous Catheter Force-Activated Separation Device.
General Hospital
The Intravenous Catheter Force-Activated Separation Device is placed inline with an IV catheter and an intravascular administration set; it separates into two parts when a specified force is applied, intended to reduce the risk of IV catheter failures requiring replacement by providing a controlled breakaway point. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 880.5220 in the General Hospital specialty. It carries product code QOI and is not an implant and not life-sustaining.
510(k) Clearances
8 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.