Cleared Traditional

CO-STAT(TM) END TIDAL BREATH ANALYZER (K974805) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974805 · Natus Medical, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
78d
Days
Class 2
Risk

K974805 is an FDA 510(k) clearance for the CO-STAT(TM) END TIDAL BREATH ANALYZER. Classified as Assay, Carboxyhemoglobin (product code GHS), Class II - Special Controls.

Submitted by Natus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Natus Medical, Inc. devices

Submission Details

510(k) Number K974805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1997
Decision Date March 11, 1998
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHS Assay, Carboxyhemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.