Cleared Traditional

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (K122290) - FDA 510(k) Clearance

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

K122290 · Envitec-Wismar GmbH · Anesthesiology device
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Jan 2013
Decision
177d
Days
Class 2
Risk

K122290 is an FDA 510(k) clearance for the ENVITEC MYSIGN O OXYGEN MEASURING DEVICE. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Envitec-Wismar GmbH (Egale, US). The FDA issued a Cleared decision on January 23, 2013 after a review of 177 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 Envitec-Wismar GmbH devices

Submission Details

510(k) Number K122290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date January 23, 2013
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
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 18
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K122290.
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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
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · Invacare Corp. · Jul 1999