Cleared Traditional

K952694 - CO BREATH ANALYSIS MODULE & MONOXOL II

K952694 is an FDA 510(k) clearance for CO BREATH ANALYSIS MODULE & MONOXOL II, manufactured by Bacharach, Inc.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K952694 · Bacharach, Inc. · Anesthesiology device
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Jan 1996
Decision
229d
Days
Class 2
Risk

K952694 is an FDA 510(k) clearance for the CO BREATH ANALYSIS MODULE & MONOXOL II. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bacharach, Inc. (Bethesda, US). The FDA issued a Cleared decision on January 29, 1996 after a review of 229 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 Bacharach, Inc. devices

FDA 510(k) Submission Details - K952694

510(k) Number K952694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date January 29, 1996
Days to Decision 229 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 140d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

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

All 21
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K952694.
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