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EC50 Micro+ Smokerlyzer

by Bedfont Scientific Ltd

510(k) K082315

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082315↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK082315 Date1 Feb 2010ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082315 decided 1 Feb 2010 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
CCJ
FDA applicant
Bedfont Scientific, Ltd.
Device class
Class II
Regulation
21 CFR Part 868.1430
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K082315

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K082315
UDI-DISize and differences
Smokerlyzer Micro+
BEDFONT SCIENTIFIC LIMITED
MICROADV / Micro+05060246860047 —On the market

Similar devices

Other devices filed under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).

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