# K974805: CO-Stat (TM) End Tidal Breath Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical, Inc.
- Decided: Mar 11, 1998 after 78 days
- Product code: GHS (Assay, Carboxyhemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770209 (1977). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902113: Vitalograph - Breathco Monitor, Mcneill Intl., Inc. (1990) Summary page 1.
- K935272: CAP 400 AT, Pryon Corp. (1994) Summary page 1.
- K770209: Ecolyzer Carboximeter, Iadec, Inc. (1977) Summary page 1.

## Indications for use
The Natus Breath Analyzer is intended for non-invasive. quantitative measurement of respiratory rate, end tidal carbon dioxide concentration, and end tidal carbon monoxide (corrected for background carbon monoxide) concentration in the breath. The analyzer is intended for use with neonates, children, and adults breathing spontaneously. The analyzer measures the carbon monoxide concentration in end tidal breath, as an indicator of the blood level of COHb. The level of COHb (and consequently the concentration of carbon monoxide in the end tidal breath) can be affected by endogenous sources (for example the rate of hemolysis), exogenous sources (for example, combustion engine exhaust), or in some cases both. The COHb level, elevated or normal, can be used in the diagnosis of medical conditions in which the rate of hemolysis may be relevant, and in the monitoring of patient populations affectzd by the rate of hemolysis. The analyzer is also indicated for use in respiratory status evaluation, whenever measurements of respiratory rate and end tidal carbon dioxide concentration are desired. The analyzer is intended for use under the direction of a physician in hospitals and a variety of health care settings.

Source page: https://510kreport.com/device/K974805
Methodology: https://510kreport.com/methodology