Cleared Traditional

K211918 - iCOquit® Smokerlyzer® (FDA 510(k) Clearance)

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

K211918 · Bedfont Scientific, Ltd. · Toxicology device
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Dec 2021
Decision
183d
Days
Class 2
Risk

K211918 is an FDA 510(k) clearance for the iCOquit® Smokerlyzer®. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on December 21, 2021 after a review of 183 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bedfont Scientific, Ltd. devices

Submission Details

510(k) Number K211918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date December 21, 2021
Days to Decision 183 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 87d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.