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.
Regulator, Vacuum
General Hospital
A vacuum regulator is a device used in hospital settings to control and maintain the level of negative pressure (suction) delivered to a patient or clinical application from a central vacuum system, used for wound drainage, airway suctioning, or fluid aspiration. It is classified as an FDA Class 2 device, indicating moderate risk, and requires premarket clearance or a 510(k) submission. Product code KDP is regulated under 21 CFR 880.6740 in the General Hospital medical specialty. No additional special flags apply to this device.
510(k) Clearances
21 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.