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.
Free to try · every answer cites its records
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Unknown
The COVID-19 Multi-Analyte Respiratory Panel Nucleic Acid Device is a not-classified in vitro diagnostic device using nucleic acid-based technology for the simultaneous qualitative detection and differentiation of SARS-CoV-2 and common respiratory microorganisms in human respiratory specimens, authorized under Emergency Use Authorization during the COVID-19 public health emergency; results are not intended to be used as the sole basis for diagnosis or patient management decisions. The product code is QLT, reviewed by the Microbiology panel. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "QLT". 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.