Cleared Special

K131945 - GE DATEX-OHMEDA AVANCE CS2

K131945 is an FDA 510(k) clearance for GE DATEX-OHMEDA AVANCE CS2, 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 42-day FDA review.

K131945 · Datex-Ohmeda · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
42d
Days
Class 2
Risk

K131945 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AVANCE CS2. 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 August 8, 2013 after a review of 42 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 - K131945

510(k) Number K131945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date August 08, 2013
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
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 K131945.
A9800 ANESTHESIA WORKSTATION
K131790 · Oricare, Inc. · May 2014
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K133958 · Maquet Critical Care AB · Mar 2014
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K132530 · Datex-Ohmeda, Inc. · Dec 2013
INTELLISAVE AX700 ANESTHESIA SYSTEM
K122063 · Philips Anesthesia Care · Aug 2013
A5 ANESTHESIA DELIVERY SYSTEM
K123211 · Datascope Corp., Patient Monitoring Division · Feb 2013
GE DATEX-OHMEDA AVANCE CS2
K123125 · Datex-Ohmeda, Inc. · Feb 2013
K131945 · GE DATEX-OHMEDA AVANCE CS2
Download PDF FDA Summary Datex-Ohmeda