Cleared Special

K051895 - GE DATEX-OHMEDA ENGSTROM CARESTATION

K051895 is an FDA 510(k) clearance for GE DATEX-OHMEDA ENGSTROM CARESTATION, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 76-day FDA review.

K051895 · Datex-Ohmeda, Inc. · Anesthesiology device
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Sep 2005
Decision
76d
Days
Class 2
Risk

K051895 is an FDA 510(k) clearance for the GE DATEX-OHMEDA ENGSTROM CARESTATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on September 27, 2005 after a review of 76 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K051895

510(k) Number K051895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date September 27, 2005
Days to Decision 76 days
Submission Type Special
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
64d faster than avg
Panel avg: 140d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

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 422
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K051895.
IVENT 201
K053270 · Versamed Medical Systems, Inc. · Jan 2006
NEWPORT E360 VENTILATOR
K053502 · Newport Medical Instruments, Inc. · Jan 2006
RAPHAEL COLOR
K052863 · Hamilton Medical AG · Jan 2006
AV-S ANAESTHESIA VENTILATOR
K051222 · Penlon Limited · Sep 2005
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
K052554 · Versamed Medical Systems, Inc. · Sep 2005
LTV 1000 VENTILATOR
K051767 · Pulmonetic Systems, Inc. · Jul 2005