510(k) Report

510(k) · Cleared

Cleared

CO-Stat (TM) End Tidal Breath Analyzer

K974805510(k) TraditionalCleared Mar 11, 199878-day reviewClass II21 CFR 864.7425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Natus Medical, Inc. · GHS Assay, Carboxyhemoglobin

Cleared on Mar 11, 1998 as substantially equivalent to K902113 (Mcneill Intl., Inc., 1990) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1977.

Decided
Mar 11, 1998
Review
78 days
Class
Class II
Product code
GHS
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K770209 (1977). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1990: 1 other ancestorK770209 · Ecolyzer Carboximeter · Iadec, Inc. · 1977197519801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K770209 · Ecolyzer Carboximeter · Iadec, Inc. · 19770
  1. Root · 1 generation backK770209 Ecolyzer CarboximeterIadec, Inc. · 1977
  2. This deviceK974805 CO-Stat (TM) End Tidal Breath AnalyzerNatus Medical, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770209Ecolyzer CarboximeterIadec, Inc.1977—
0 (this device)K974805CO-Stat (TM) End Tidal Breath AnalyzerNatus Medical, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410
FIG. 1 — Lineage of K974805, 1977–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K902113Vitalograph - Breathco Monitor
Summary page 1
…Analyzer is substantially equivalent. Manufacturer Common name Device Classification Product Code K# Class Panel Vitalograph Carbon monoxide O |Anesthesiology |73 CCJ K902113A gas analyzer ) Pryon Carbon dioxide gas II iAnesthesiology {73 CCK K935272 analyzer Tadec Carboxyhemoglobin O Hematology GHS K…
Mcneill Intl., Inc.1990—
*K935272CAP 400 AT
Summary page 1
…fication Product Code K# Class Panel Vitalograph Carbon monoxide O |Anesthesiology |73 CCJ K902113A gas analyzer ) Pryon Carbon dioxide gas II iAnesthesiology {73 CCK K935272 analyzer Tadec Carboxyhemoglobin O Hematology GHS K770209 assay ; Table 2: Predicate Devices 4, Device Intended Use The Natus…
Pryon Corp.1994—
*K770209Ecolyzer Carboximeter
Summary page 1
…noxide O |Anesthesiology |73 CCJ K902113A gas analyzer ) Pryon Carbon dioxide gas II iAnesthesiology {73 CCK K935272 analyzer Tadec Carboxyhemoglobin O Hematology GHS K770209 assay ; Table 2: Predicate Devices 4, Device Intended Use The Natus Breath Analyzer is intended for non-invasive measurement o…
Iadec, Inc.1977—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.

How does its category compare?

All GHS devices

GHS Assay, Carboxyhemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GHS

FDA has decided no GHS device since 2007.

Median 510(k) review, days · GHS

Too few GHS 510(k)s in any year since 2007 to give a median.

Recalls per year · GHS

No recall names GHS since 2007.

Adverse event reports per year · GHS

No MAUDE report names GHS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.…

Read the full statement (187 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Natus Medical, Inc.

12 FDA decisions under this applicant name. See the company

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  • K093949Olympic Brainz Monitor Model OBM70001Natus Medical, Inc. · 2010
  • K090019Natus Neuroworks, Model 104196Natus Medical, Inc. · 20101 recall
  • K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc. · 2009
  • K073665Algo 5 Newborn Hearing ScreenerNatus Medical, Inc. · 2008

Recent decisions in GHS

The GHS category page

  • K910827ABL520 Blood Gas SystemRadiometer America, Inc. · 1991
  • K790943Trisedta-Borate Electrophoresis Film AgaCorning Medical & Scientific · 1979
  • K771263Radiomhter Osm-2 HemoximeterThe London Co. · 1977
  • K770209Ecolyzer CarboximeterIadec, Inc. · 1977

https://510kreport.com/device/K974805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974805: CO-Stat (TM) End Tidal Breath Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974805

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026