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.
Mechanical Ventilator
Anesthesiology
The Mechanical Ventilator (product code ONZ) is a Class 2 anesthesiology device regulated under 21 CFR 868.5895 in the Anesthesiology specialty (AN), cleared via 510(k). It is a volume assist ventilator designed for adult patients with respiratory insufficiency who can spontaneously breathe a minimum tidal volume of 3.5 cc/kg of predicted body weight, intended for continuous use during patient ambulation, physical therapy, and rehabilitation in institutional or home care environments under physician direction. The device is not flagged as an implant or life-sustaining in the FDA record, though it supports respiratory function.
510(k) Clearances
6 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.