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.
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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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Transport Medium, Notified Per The Vtm Guidance
Microbiology
The Transport Medium notified per the VTM Guidance is a specimen collection and transport device intended for use in the detection of respiratory viruses including coronavirus, as outlined in the FDA's guidance on notified transport media. It is a Class 1 device subject to general controls under regulation 866.2390 in the Microbiology specialty. Product code QMC. As a Class 1 device it is the lowest regulatory tier, relying on general controls to ensure safety and effectiveness, though it is not GMP exempt in this case. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "QMC". 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.