Cleared Traditional

K060862 - GE DATEX-OHMEDA ENGSTROM CARESTATION

K060862 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 Traditional 510(k) pathway after a 68-day FDA review.

K060862 · Datex-Ohmeda, Inc. · Anesthesiology device
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Jun 2006
Decision
68d
Days
Class 2
Risk

K060862 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 June 5, 2006 after a review of 68 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 Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K060862

510(k) Number K060862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2006
Decision Date June 05, 2006
Days to Decision 68 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
72d faster than avg
Panel avg: 140d · This submission: 68d
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 K060862.
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K063650 · Puritan Bennett Corp. · Feb 2007
GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · Datex-Ohmeda, Inc. · Dec 2006
GALILEO GOLD ASV
K061090 · Hamilton Medical AG · Jul 2006
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K053388 · Puritan Bennett Corp. · Apr 2006
RAPHAEL COLOR
K052863 · Hamilton Medical AG · Jan 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · Datex-Ohmeda, Inc. · Sep 2005