Cleared Traditional

K082655 - ENVITEC MEDICAL OXYGEN SENORS

Also marketed or referenced as:
00M102/-1 OOM103/-1/-1M OOM104 OOM105 00M106

K082655 is an FDA 510(k) clearance for ENVITEC MEDICAL OXYGEN SENORS, 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 74-day FDA review.

K082655 · Envitec-Wismar GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
74d
Days
Class 2
Risk

K082655 is an FDA 510(k) clearance for the ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101. 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 November 25, 2008 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Envitec-Wismar GmbH devices

FDA 510(k) Submission Details - K082655

510(k) Number K082655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date November 25, 2008
Days to Decision 74 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
66d faster than avg
Panel avg: 140d · This submission: 74d
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 50
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K082655.
OxyMinder
K213948 · Bio-Med Devices, Inc. · Mar 2022
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
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999