Cleared Traditional

K031741 - MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300

K031741 is an FDA 510(k) clearance for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), manufactured by Alaris Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K031741 · Alaris Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
250d
Days
Class 2
Risk

K031741 is an FDA 510(k) clearance for the MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on February 9, 2004 after a review of 250 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031741

510(k) Number K031741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2003
Decision Date February 09, 2004
Days to Decision 250 days
Submission Type Traditional
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
110d slower than avg
Panel avg: 140d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 275
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K031741.
MODIFICATION TO NICO WITH MARS, MODEL 7300
K041450 · Respironics Novametrix, Inc. · Jun 2004
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
K040847 · Draeger Medical, Inc. · Jun 2004
POLARIS 2004 CAPNOGRAPH
K040011 · Oridion , Ltd. · May 2004
NICO WITH MARS, MODEL 7300
K030886 · Respironics Novametrix, Inc. · Oct 2003
ADVISOR, MODEL 9200
K030407 · Bci, Inc. · Aug 2003
STATCO2METER, MODEL 10-55372
K031814 · Mercury Medical · Aug 2003
K031741 · MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
Download PDF FDA Summary Alaris Medical System…