Cleared Special

K012394 - ORIDION MAC-LINE ORAL NASAL CANNULA SAM...

K012394 is the FDA 510(k) clearance for ORIDION MAC-LINE ORAL NASAL CANNULA SAM... by Oridion Medical 1987 , Ltd.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Special 510(k) pathway after a 19-day FDA review.

K012394 · Oridion Medical 1987 , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
19d
Days
Class 2
Risk

K012394 is an FDA 510(k) clearance for the ORIDION MAC-LINE ORAL 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.

View all Oridion Medical 1987 , Ltd. devices

Submission Details

510(k) Number K012394 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
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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