Cleared Traditional

Maxtec MaxO2 ME+p (K221734) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221734 · Maxtec, LLC · Anesthesiology device
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Apr 2023
Decision
290d
Days
Class 2
Risk

K221734 is an FDA 510(k) clearance for the Maxtec MaxO2 ME+p. 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 April 1, 2023 after a review of 290 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

Submission Details

510(k) Number K221734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2022
Decision Date April 01, 2023
Days to Decision 290 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
150d slower than avg
Panel avg: 140d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K221734.
OxyMinder Pro (10310)
K251245 · Bio-Med Device, Inc. · Aug 2025
Smart Check O2 (MA0236)
K250002 · Life Spark Medical, LLC · Apr 2025
Percent Oxygen Sensors
K213933 · Careox, LLC · Aug 2022
OxyMinder
K213948 · Bio-Med Devices, Inc. · Mar 2022
Accu O2 Oxygen Analyzer
K173807 · Precision Medical, Inc. · May 2018
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