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.
Monitor, Bed Patient
General Hospital
A Bed Patient Monitor is a device used in hospital and long-term care settings to detect patient movement or the absence thereof, alerting caregivers when a patient attempts to exit the bed or has not moved for a specified period, supporting fall prevention and patient safety. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KMI and it is regulated under 21 CFR 880.2400 in the General Hospital specialty.
510(k) Clearances
31 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.