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.
Phenolphthalein Colorimetry, Carbon-Dioxide
Clinical Chemistry
The Phenolphthalein Colorimetry Carbon Dioxide test is an in vitro diagnostic assay used in clinical chemistry laboratories to measure total carbon dioxide or bicarbonate concentrations in blood or serum, providing information relevant to acid-base balance assessment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KMS and it is regulated under 21 CFR 862.1160 in the Clinical Chemistry specialty. This device is eligible for third-party review.
510(k) Clearances
5 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.