Cleared Traditional

K082315 - EC50 MICRO+ SMOKERLYZER (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082315 · Bedfont Scientific, Ltd. · Toxicology device
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Feb 2010
Decision
537d
Days
Class 2
Risk

K082315 is an FDA 510(k) clearance for the EC50 MICRO+ SMOKERLYZER. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bedfont Scientific, Ltd. (Rochester, Kent, GB). The FDA issued a Cleared decision on February 1, 2010 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 868.1430 - the FDA toxicology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Bedfont Scientific, Ltd. devices

Submission Details

510(k) Number K082315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date February 01, 2010
Days to Decision 537 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
450d slower than avg
Panel avg: 87d · This submission: 537d
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 Toxicology devices follow this clearance model.