Cleared Special

K040011 - POLARIS 2004 CAPNOGRAPH

K040011 is an FDA 510(k) clearance for POLARIS 2004 CAPNOGRAPH, manufactured by Oridion , Ltd.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 129-day FDA review.

K040011 · Oridion , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
129d
Days
Class 2
Risk

K040011 is an FDA 510(k) clearance for the POLARIS 2004 CAPNOGRAPH. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Oridion , Ltd. (Needham, US). The FDA issued a Cleared decision on May 13, 2004 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - the FDA anesthesiology and respiratory device 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040011

510(k) Number K040011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2004
Decision Date May 13, 2004
Days to Decision 129 days
Submission Type Special
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
11d faster than avg
Panel avg: 140d · This submission: 129d
Pathway characteristics
Modification to existing cleared device.

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 306
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K040011.
EMG - ESSENTIAL GAS MODULE, MODEL M1013A
K041956 · Draeget Medical AG & Co. Kgaa · Aug 2004
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
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741 · Alaris Medical Systems, Inc. · Feb 2004
NICO WITH MARS, MODEL 7300
K030886 · Respironics Novametrix, Inc. · Oct 2003
ADVISOR, MODEL 9200
K030407 · Bci, Inc. · Aug 2003
K040011 · POLARIS 2004 CAPNOGRAPH
Download PDF FDA Summary Oridion , Ltd.