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.
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
Cardiovascular
The Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate is a cardiovascular software device that uses algorithms to analyze video signals and estimate vital sign parameters including pulse rate, heart rate, and respiratory rate. It is not intended to independently direct therapy and must be used adjunctively with clinical judgment. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.2785 in the Cardiovascular specialty. It carries product code QME and is not an implant and not life-sustaining.
510(k) Clearances
13 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.