Cleared Special

K071142 - GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM

K071142 is an FDA 510(k) clearance for GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM, manufactured by Datex-Ohmeda. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 43-day FDA review.

K071142 · Datex-Ohmeda · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
43d
Days
Class 2
Risk

K071142 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda (Madison, US). The FDA issued a Cleared decision on June 6, 2007 after a review of 43 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.

FDA 510(k) Submission Details - K071142

510(k) Number K071142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2007
Decision Date June 06, 2007
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
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 183
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K071142.
GE DATEX-OHMEDA AISYS
K073707 · Datex-Ohmeda, Inc. · Jan 2008
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
K072420 · Oceanic Medical Products, Inc. · Jan 2008
NAVIGATOR APPLICATIONS SUITE
K071097 · GE Healthcare Finland Oy · Oct 2007
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
K062388 · Docusys · Feb 2007
DIGITAL MXR-D FLOWMETER
K062155 · Porter Instrument Co., Inc. · Nov 2006
PRIMA ANAESTHESIA MACHINE
K061102 · Penlon , Ltd. · Jul 2006
K071142 · GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
Download PDF FDA Summary Datex-Ohmeda