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.
Oximeter, Fetal Pulse
Unknown
The Fetal Pulse Oximeter is a device used during labor and delivery to non-invasively monitor the oxygen saturation of fetal blood, typically by attaching a sensor to the fetal presenting part, providing real-time assessment of fetal oxygenation to guide obstetric management during labor. As a Class 3 device, it requires Premarket Approval (PMA) reflecting the significant risks associated with fetal monitoring and the critical nature of its intended clinical application. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.
No 510(k) clearances found for "MMA". 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.