Cleared Special

PICO SMOKERLYZER, MODEL EC-50 (K000962) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K000962 · Bedfont Scientific, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
27d
Days
Class 2
Risk

K000962 is an FDA 510(k) clearance for the PICO SMOKERLYZER, MODEL EC-50. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Bedfont Scientific, Ltd. (Upchurch, Kent, GB). The FDA issued a Cleared decision on April 20, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.1430 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bedfont Scientific, Ltd. devices

Submission Details

510(k) Number K000962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2000
Decision Date April 20, 2000
Days to Decision 27 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 Chemistry devices follow this clearance model.

Regulatory Peers - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 8
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K000962.
Pivot Breath Sensor
K201206 · Carrot, Inc. · Jun 2021
ToxCO
K173238 · Bedfont Scientific, Ltd. · Apr 2019
CO Check Pro, CO Screen
K171129 · MD Diagnostics Limited · Mar 2018
ECOLYZER #200/COHB ANALYZER SYS
K832655 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891 · Sherwood Medical Co. · Dec 1980
DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
K760169 · Hewlett-Packard Co. · Jul 1976