Cleared Traditional

K153659 - MaxO2ME

K153659 is an FDA 510(k) clearance for MaxO2ME, manufactured by Maxtec, LLC. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K153659 · Maxtec, LLC · Anesthesiology device
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Jun 2016
Decision
172d
Days
Class 2
Risk

K153659 is an FDA 510(k) clearance for the MaxO2ME. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on June 10, 2016 after a review of 172 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Maxtec, LLC devices

FDA 510(k) Submission Details - K153659

510(k) Number K153659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date June 10, 2016
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 43
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K153659.
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K213933 · Careox, LLC · Aug 2022
OxyMinder
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Accu O2 Oxygen Analyzer
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CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · GE Healthcare Finland Oy · Feb 2013
PRECISION OXYGEN MONITOR
K063096 · Precision Medical, Inc. · Feb 2007
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
K051092 · Ge Healthcare · May 2005