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.
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
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The Remote or Wearable Patient Monitoring Device for Drug-Induced QT Prolongation Monitoring is a cardiovascular device used by healthcare professionals in hospital settings to remotely monitor and detect changes in the QT interval of an ECG in general care patients aged 18 or older who are undergoing treatment with drugs that can prolong QT intervals and may cause life-threatening arrhythmias. Authorized under an FDA Emergency Use Authorization (EUA) during a declared public health emergency, it is not formally classified by device class. Product code QNY, reviewed by the Cardiovascular panel. The device is not an implant and is not life-sustaining.
No 510(k) clearances found for "QNY". 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.