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.
System, Monitoring, For Progress Of Labor
Ophthalmic
The labor progress monitoring system is an obstetric device that provides intrapartum measurement of cervical dilation, fetal head station, and other sentinel anatomical markers to adjunctively assist clinicians in following the progress of labor alongside other diagnostic information. It is classified as FDA Class 2 under regulation 884.2800, reviewed by the Obstetrics/Gynecology panel (though listed under Ophthalmic specialty, likely a data entry discrepancy), requiring 510(k) clearance. Product code NPB is not eligible for third-party review.
510(k) Clearances
4 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.