Cleared Special

K042154 - GE DATEX-OHMEDA AISYS CARESTATION

K042154 is an FDA 510(k) clearance for GE DATEX-OHMEDA AISYS CARESTATION, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 21-day FDA review.

K042154 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
21d
Days
Class 2
Risk

K042154 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AISYS CARESTATION. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 21 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 Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K042154

510(k) Number K042154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2004
Decision Date August 31, 2004
Days to Decision 21 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
119d faster than avg
Panel avg: 140d · This submission: 21d
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 K042154.
PRIMUS US
K042607 · Draeger Medical, Inc. · Nov 2004
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419 · Draeger Medical, Inc. · Oct 2004
FABIUS GS ANESTHESIA SYSTEM
K042086 · Draeger Medical, Inc. · Aug 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K041622 · Draeger Medical, Inc. · Jul 2004
NARKOMED 6400, MODEL NM6400
K033498 · Draeger Medical, Inc. · Apr 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743 · Datex-Ohmeda, Inc. · Apr 2004