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EC50 Micro+ Smokerlyzer

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K082315

by Bedfont Scientific Ltd

Identifiers

510(k) Number
K082315 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 EC50 Micro+ Smokerlyzer is a Carbon-Monoxide Analyzer, Gaseous-Phase, designed to measure exhaled carbon monoxide (CO) levels in breath. Classified as a Class II device under FDA regulations, it quantifies CO concentrations to assess smoking exposure or tobacco use, aiding in clinical or advisory evaluations within anesthesiology or related specialties.

This device is supplied as a reusable, non-sterile instrument intended for use in clinical or research settings. It operates via a disposable sampling cassette and requires calibration per manufacturer instructions. Authorized under FDA 510K and MDR, the EC50 Micro+ adheres to regulatory standards for gas-phase analyzers, with no MRI compatibility specified. Storage conditions are not detailed but should follow standard environmental guidelines for electronic medical devices.

Frequently asked questions

What clinical specialties is the EC50 Micro+ Smokerlyzer primarily used in, and why is it relevant to those fields?

The EC50 Micro+ Smokerlyzer is primarily relevant to anesthesiology and related clinical or research settings. It measures exhaled carbon monoxide (CO) levels to assess smoking exposure or tobacco use, which can be critical in preoperative evaluations, patient risk stratification, or research studies where tobacco history impacts outcomes. The device aids in quantifying CO concentrations, helping clinicians or researchers make informed decisions based on smoking-related biomarkers.

Is the EC50 Micro+ Smokerlyzer a single-use or reusable device, and what does that mean for its maintenance?

The EC50 Micro+ Smokerlyzer is a reusable instrument, but it relies on disposable sampling cassettes for each use. This design means the main analyzer unit can be cleaned and recalibrated per manufacturer instructions, while the cassettes are replaced after single-use. Proper maintenance of the reusable components—such as cleaning and calibration—ensures accurate CO measurements over time.

How do I determine the correct storage conditions for the EC50 Micro+ Smokerlyzer, and why is this important?

While the device specifications do not detail exact storage conditions, it is an electronic medical device, so it should be stored in a clean, dry environment protected from extreme temperatures, humidity, and direct sunlight. Proper storage prevents damage to sensitive electronics and ensures the device’s accuracy and longevity, as CO analyzers require stable operating conditions for reliable performance.

What regulatory pathways does the EC50 Micro+ Smokerlyzer follow, and how does that affect its use in clinical settings?

The EC50 Micro+ Smokerlyzer is authorized under FDA 510(k) clearance and MDR (Medical Device Regulation) in the EU, confirming it meets regulatory standards for gas-phase analyzers. This means it has undergone evaluation for safety and performance, allowing its use in clinical or research settings where exhaled CO measurement is relevant—such as smoking cessation programs or preoperative assessments—while adhering to established medical device compliance requirements.

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

Manufacturer
Bedfont Scientific Ltd
FDA Applicant
Bedfont Scientific, Ltd.

Sources (2)

  • FDA 510(k) K082315 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026