Cleared Traditional

K892841 - BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR

K892841 is an FDA 510(k) clearance for BEDFONT EC50 SMOKERLYZER CARBON MONOXID..., manufactured by Bedfont Technical Instruments , Ltd.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K892841

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.

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 26
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K892841.
SPIROLOOP, MODIFICATION
K904633 · Pneumedics, Inc. · Mar 1991
VITALOGRAPH - BREATHCO MONITOR
K902113 · Mcneill Intl., Inc. · Oct 1990
CO/CMD-1
K900322 · Spirometrics, Inc. · Apr 1990
VITALOGRAPH-BREATHCO MONITOR
K892524 · Vitalograph , Ltd. · May 1989
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420 · Vitalograph , Ltd. · Jan 1987
CO TEST
K843845 · Erich Jaeger, Inc. · Oct 1984
K892841 · BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
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