Cleared Traditional

K082655 - ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101 (FDA 510(k) Clearance)

Also includes:
00M102/-1 OOM103/-1/-1M OOM104 OOM105 00M106

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

K082655 · Envitec-Wismar GmbH · Anesthesiology device
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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

Submission Details

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
65d faster than avg
Panel avg: 139d · This submission: 74d
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.