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iCOquit Smokerlyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211918

by Bedfont Scientific Ltd

Identifiers

510(k) Number
K211918 FDA 510(k)
FDA Product Code
CCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1430 FDA 510(k)
Regulation Number
868.1430 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The iCOquit Smokerlyzer is a Carbon-Monoxide Gas Analyzer designed to measure exhaled carbon monoxide (CO) levels in gaseous phase. It functions as a diagnostic tool to assess smoking status, monitor smoking cessation progress, and evaluate exposure to environmental tobacco smoke by quantifying CO concentrations in breath samples.

This device is intended for use in clinical, research, and home settings, supplied as a reusable instrument with disposable mouthpieces. It operates under FDA 510(k) clearance and EU MDR compliance, classified as a Class II medical device. The system requires calibration and maintenance as specified by the manufacturer, with no MRI safety restrictions noted. Multiple model variants are available, distinguished by their registration numbers.

Frequently asked questions

What clinical or research settings is the iCOquit Smokerlyzer primarily used in, and how does it help in those environments?

The iCOquit Smokerlyzer is designed for use in clinical, research, and home settings to measure exhaled carbon monoxide (CO) levels. Clinically, it helps assess a patient’s smoking status and monitor progress during smoking cessation by quantifying CO exposure. In research, it provides objective data on tobacco smoke exposure, including environmental tobacco smoke, supporting studies on smoking behaviors and public health interventions. The device’s portability and disposable mouthpieces make it practical for diverse use cases.

Is the iCOquit Smokerlyzer a single-use or reusable device, and what does that mean for maintenance?

The iCOquit Smokerlyzer is a reusable instrument, but it includes disposable mouthpieces for each use. This design ensures hygiene and reduces cross-contamination between users. However, the reusable components—such as the main analyzer unit—require regular calibration and maintenance as outlined by the manufacturer to ensure accurate CO measurements over time. The manufacturer’s guidelines must be followed to sustain performance.

Are there different models of the iCOquit Smokerlyzer, and how can I identify which one I need?

Yes, the iCOquit Smokerlyzer comes in multiple model variants, each distinguished by unique registration numbers (e.g., 3009896423, 3033509895, etc.). These variants may differ in features or specifications, though the core function remains the same: measuring exhaled CO. To determine the correct model, check the registration number listed on the device or consult the manufacturer’s documentation or support team, as compatibility may depend on your specific use case (e.g., clinical vs. home settings).

How should the iCOquit Smokerlyzer be stored, and are there any special handling requirements?

The iCOquit Smokerlyzer is a reusable device, so storage should follow the manufacturer’s instructions to preserve its functionality and accuracy. While specific storage conditions aren’t detailed in the data, typical guidelines for similar gas analyzers include keeping the device in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of CO contamination (e.g., cigarette smoke). Disposable mouthpieces should be stored separately in a sealed, sterile packaging until use. Always refer to the manufacturer’s user manual for precise storage recommendations.

What regulatory pathways does the iCOquit Smokerlyzer follow, and how does that affect its use?

The iCOquit Smokerlyzer is cleared under FDA 510(k) (K211918) and complies with EU MDR (Medical Device Regulation), classifying it as a Class II device. This means it has undergone rigorous review to ensure safety and performance for its intended use—measuring exhaled CO to assess smoking status or environmental exposure. The regulatory clearance confirms its suitability for clinical, research, and home use, but users should always follow the manufacturer’s instructions and local regulations to ensure proper operation and compliance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

FDA Applicant
Bedfont Scientific, Ltd.

Sources (2)

  • FDA 510(k) K211918 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026