Cleared Special

K011536 - MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

K011536 is an FDA 510(k) clearance for MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE, 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 180-day FDA review.

K011536 · Oridion Medical 1987 , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
180d
Days
Class 2
Risk

K011536 is an FDA 510(k) clearance for the MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE. 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 November 14, 2001 after a review of 180 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. 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 - K011536

510(k) Number K011536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date November 14, 2001
Days to Decision 180 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
40d slower than avg
Panel avg: 140d · This submission: 180d
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 K011536.
OXYARM CO2
K014211 · Southmedic, Inc. · Jun 2002
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
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
K012391 · Oridion Medical 1987 , Ltd. · Aug 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
K011536 · MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
Download PDF FDA Summary Oridion Medical 1987 …