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.
Monitor, Heart Rate, Fetal, Ultrasonic
Obstetrics/Gynecology
The Fetal Ultrasonic Heart Rate Monitor is a device that uses ultrasound (Doppler technology) to detect and display the fetal heart rate, enabling clinicians to assess fetal wellbeing continuously or intermittently during pregnancy or labor. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEL, regulated under 21 CFR 884.2660, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
510(k) Clearances
7 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.