Cleared Traditional

K070259 - EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR

K070259 is an FDA 510(k) clearance for EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR, manufactured by Bedfont Scientific, Ltd.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K070259 · Bedfont Scientific, Ltd. · Anesthesiology device
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Feb 2008
Decision
391d
Days
Class 2
Risk

K070259 is an FDA 510(k) clearance for the EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bedfont Scientific, Ltd. (Crofton, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Scientific, Ltd. devices

FDA 510(k) Submission Details - K070259

510(k) Number K070259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2007
Decision Date February 21, 2008
Days to Decision 391 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 140d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

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