Cleared Traditional

K082600 - OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) (FDA 510(k) Clearance)

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

K082600 · Draeger Medical B.V. · Anesthesiology device
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Nov 2008
Decision
79d
Days
Class 2
Risk

K082600 is an FDA 510(k) clearance for the OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL.... Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical B.V. (Telford, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Draeger Medical B.V. devices

Submission Details

510(k) Number K082600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date November 26, 2008
Days to Decision 79 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
60d faster than avg
Panel avg: 139d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 503
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