Cleared Traditional

K103625 - OXYLOG 3000 PLUS WORKSTATION

K103625 is an FDA 510(k) clearance for OXYLOG 3000 PLUS WORKSTATION, manufactured by Draeger Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K103625 · Draeger Medical Systems, Inc. · Anesthesiology device
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Oct 2011
Decision
300d
Days
Class 2
Risk

K103625 is an FDA 510(k) clearance for the OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on October 6, 2011 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Draeger Medical Systems, Inc. devices

FDA 510(k) Submission Details - K103625

510(k) Number K103625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2010
Decision Date October 06, 2011
Days to Decision 300 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
160d slower than avg
Panel avg: 140d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K103625.
HAMILTON-TC1
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K103803 · Hamilton Medical AG · Nov 2011
TRILOGY SERIES VENTILATOR WITH OXIMETRY
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ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K111116 · Datex-Ohmeda · Sep 2011
AVEA VENTILATOR
K103211 · Care Fusion · May 2011
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
K103318 · Impact Instrumentation, Inc. · Apr 2011