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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Ovarian Adnexal Mass Assessment Score Test System
Obstetrics/Gynecology
The Ovarian Adnexal Mass Assessment Score Test System (product code ONX) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.6050 in the Obstetrics/Gynecology specialty (OB), cleared via 510(k) and reviewed by the Immunology panel. It measures one or more serum proteins to generate a single result indicating the likelihood that an adnexal pelvic mass is malignant in women for whom surgery is planned, serving as an adjunctive aid in a negative primary clinical and radiological evaluation to identify patients requiring oncology surgical expertise. The device is eligible for third-party review and is not an implant or life-sustaining device.
510(k) Clearances
6 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.