Cleared Special

K012391 - MAC-LINE CO2 NASAL CANNULA SAMPLE LINE

K012391 is an FDA 510(k) clearance for MAC-LINE CO2 NASAL CANNULA SAMPLE LINE, manufactured by Oridion Medical 1987 , Ltd.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 19-day FDA review.

K012391 · Oridion Medical 1987 , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
19d
Days
Class 2
Risk

K012391 is an FDA 510(k) clearance for the MAC-LINE CO2 NASAL CANNULA SAMPLE LINE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Oridion Medical 1987 , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on August 15, 2001 after a review of 19 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K012391

510(k) Number K012391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2001
Decision Date August 15, 2001
Days to Decision 19 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
121d faster than avg
Panel avg: 140d · This submission: 19d
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 K012391.
VAMOS ANESTHETIC GAS MONITOR
K012139 · Draeger Medical, Inc. · Jan 2002
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
K013845 · Oridion Medical 1987 , Ltd. · Nov 2001
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
K011536 · Oridion Medical 1987 , Ltd. · Nov 2001
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE
K012394 · Oridion Medical 1987 , Ltd. · Aug 2001
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
K012395 · Oridion Medical 1987 , Ltd. · Aug 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
K011050 · Oridion Medical 1987 , Ltd. · May 2001
K012391 · MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
Download PDF FDA Summary Oridion Medical 1987 …