Cleared Traditional

K892841 - BEDFONT EC50 SMOKERLYZER CARBON MONOXID...

K892841 is the FDA 510(k) clearance for BEDFONT EC50 SMOKERLYZER CARBON MONOXID... by Bedfont Technical Instruments , Ltd.. It is a Class 2 Anesthesiology device (product code CCJ) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K892841 · Bedfont Technical Instruments , Ltd. · Anesthesiology device
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Oct 1989
Decision
170d
Days
Class 2
Risk

K892841 is an FDA 510(k) clearance for the BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bedfont Technical Instruments , Ltd. (Me9 7hn England, GB). The FDA issued a Cleared decision on October 5, 1989 after a review of 170 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 Bedfont Technical Instruments , Ltd. devices

Submission Details

510(k) Number K892841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date October 05, 1989
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 140d · This submission: 170d
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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