Cleared Special

K094012 - CAPNOSTREAM20 WITH MICROMEDICO2 MODULE

K094012 is an FDA 510(k) clearance for CAPNOSTREAM20 WITH MICROMEDICO2 MODULE, manufactured by Oridion Capnography, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 134-day FDA review.

K094012 · Oridion Capnography, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
134d
Days
Class 2
Risk

K094012 is an FDA 510(k) clearance for the CAPNOSTREAM20 WITH MICROMEDICO2 MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Oridion Capnography, Inc. (Needham, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 134 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 - K094012

510(k) Number K094012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2009
Decision Date May 12, 2010
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
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 266
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