Cleared Traditional

K902113 - VITALOGRAPH - BREATHCO MONITOR

K902113 is the FDA 510(k) clearance for VITALOGRAPH - BREATHCO MONITOR by Mcneill Intl., Inc.. It is a Class 2 Anesthesiology device (product code CCJ) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K902113 · Mcneill Intl., Inc. · Anesthesiology device
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Oct 1990
Decision
168d
Days
Class 2
Risk

K902113 is an FDA 510(k) clearance for the VITALOGRAPH - BREATHCO MONITOR. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Mcneill Intl., Inc. (Willoughby, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mcneill Intl., Inc. devices

Submission Details

510(k) Number K902113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1990
Decision Date October 26, 1990
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

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