Cleared Special

K092864 - AESPIRE 7900

K092864 is an FDA 510(k) clearance for AESPIRE 7900, manufactured by Datex-Ohmeda Inc., A Division of Instrumentarium C. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 117-day FDA review.

K092864 · Datex-Ohmeda Inc., A Division of Instrumentarium C · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
117d
Days
Class 2
Risk

K092864 is an FDA 510(k) clearance for the AESPIRE 7900, AESPIRE VIEW. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda Inc., A Division of Instrumentarium C (Madison, US). The FDA issued a Cleared decision on January 12, 2010 after a review of 117 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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., A Division of Instrumentarium C devices

FDA 510(k) Submission Details - K092864

510(k) Number K092864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2009
Decision Date January 12, 2010
Days to Decision 117 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 140d · This submission: 117d
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 111
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K092864.
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
GE DATEX-OHMEDA S/5 ADU CARESTATION
K090892 · GE Healthcare Finland Oy · Apr 2009
NAVIGATOR APPLICATIONS SUITE
K083098 · GE Healthcare Finland Oy · Apr 2009
GE DATEX-OHMEDA AISYS
K090233 · Datex-Ohmeda, Inc. · Mar 2009