Cleared Traditional

K014211 - OXYARM CO2

K014211 is an FDA 510(k) clearance for OXYARM CO2, manufactured by Southmedic, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K014211 · Southmedic, Inc. · Anesthesiology device
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Jun 2002
Decision
172d
Days
Class 2
Risk

K014211 is an FDA 510(k) clearance for the OXYARM CO2. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Southmedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on June 11, 2002 after a review of 172 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Southmedic, Inc. devices

FDA 510(k) Submission Details - K014211

510(k) Number K014211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date June 11, 2002
Days to Decision 172 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 140d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 248
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K014211.
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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