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)
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.

View all Oridion Medical 1987 , Ltd. devices

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 231
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K011536.
MULTIGAS UNIT, MODEL AG-920RA
K020046 · Nihon Kohden America, Inc. · Jul 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