Cleared Abbreviated

K002384 - M-XX OXYGEN SENSORS

K002384 is an FDA 510(k) clearance for M-XX OXYGEN SENSORS, manufactured by International Business Strategies. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Abbreviated 510(k) pathway after a 133-day FDA review.

K002384 · International Business Strategies · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
133d
Days
Class 2
Risk

K002384 is an FDA 510(k) clearance for the M-XX OXYGEN SENSORS. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by International Business Strategies (Mount Pleasant, US). The FDA issued a Cleared decision on December 15, 2000 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K002384

510(k) Number K002384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date December 15, 2000
Days to Decision 133 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Standards-based clearance path.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 83
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K002384.
PRIMA OXYGEN MONITOR
K010318 · Penlon , Ltd. · Jul 2001
'ALL 2000' % OXYGEN ANALYZER
K002382 · Analytical Industries, Inc. · Mar 2001
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
K010382 · Sensidyne, Inc. · Mar 2001
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K000700 · Sensidyne, Inc. · Aug 2000
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
K001095 · Teledyne Analytical Instruments · Jun 2000
TED 200T7 OXYGEN MONITOR
K990403 · Teledyne Electronic Technologies · Feb 2000