Cleared Traditional

K122290 - ENVITEC MYSIGN O OXYGEN MEASURING DEVICE

K122290 is an FDA 510(k) clearance for ENVITEC MYSIGN O OXYGEN MEASURING DEVICE, manufactured by Envitec-Wismar GmbH. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K122290 · Envitec-Wismar GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K122290

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
Combination Product No
PCCP Authorized No
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.

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 83
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K122290.
Accu O2 Oxygen Analyzer
K173807 · Precision Medical, Inc. · May 2018
MaxO2ME
K153659 · Maxtec, LLC · Jun 2016
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · GE Healthcare Finland Oy · Feb 2013
ULTRAMAXO2 OXYGEN ANALYER
K112402 · Maxtec, LLC · Dec 2011
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101
K082655 · Envitec-Wismar GmbH · Nov 2008
DIGIFLO CONCENTRATOR ANALYZER
K072469 · Digiflo, Inc. · Jan 2008