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.
Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Clinical Chemistry
A clinical tonometer used for calibration and quality control of blood-gas instruments is a device that introduces precisely controlled gas mixtures into blood-gas analyzers to verify their accuracy and calibration, ensuring reliable measurement of blood oxygen, carbon dioxide, and pH. It is classified as FDA Class 1, requiring only general controls with no premarket notification needed. The product code is LCH, regulated under 21 CFR 862.1660, in the Clinical Chemistry specialty. No special risk flags apply.
510(k) Clearances
9 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.