Cleared Special

K090892 - GE DATEX-OHMEDA S/5 ADU CARESTATION

K090892 is an FDA 510(k) clearance for GE DATEX-OHMEDA S/5 ADU CARESTATION, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K090892 · GE Healthcare Finland Oy · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
30d
Days
Class 2
Risk

K090892 is an FDA 510(k) clearance for the GE DATEX-OHMEDA S/5 ADU CARESTATION. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Madison, US). The FDA issued a Cleared decision on April 30, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K090892

510(k) Number K090892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2009
Decision Date April 30, 2009
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K090892.
GE DATEX-OHMEDA AVANCE
K112722 · Datex-Ohmeda, Inc. · Dec 2011
GE DATEX-OHMEDA AISYS
K110213 · Datex-Ohmeda, Inc. · Jul 2011
NAVIGATOR APPLICATIONS SUITE
K102389 · GE Healthcare Finland Oy · Jun 2011
NAVIGATOR APPLICATIONS SUITE
K083098 · GE Healthcare Finland Oy · Apr 2009
GE DATEX-OHMEDA AISYS
K090233 · Datex-Ohmeda, Inc. · Mar 2009
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
K083413 · Philips Medical Systems · Dec 2008