Cleared Special

K031400 - FABIUS TIRO ANESTHESIA SYSTEM

K031400 is an FDA 510(k) clearance for FABIUS TIRO ANESTHESIA SYSTEM, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 71-day FDA review.

K031400 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
71d
Days
Class 2
Risk

K031400 is an FDA 510(k) clearance for the FABIUS TIRO ANESTHESIA SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 71 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K031400

510(k) Number K031400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2003
Decision Date July 15, 2003
Days to Decision 71 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
69d faster than avg
Panel avg: 140d · This submission: 71d
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 K031400.
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K030624 · Draeger Medical, Inc. · Mar 2004
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803 · Datex-Ohmeda · Mar 2004
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K030939 · Philips Medical Systems · Jul 2003
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031 · Draeger Medical, Inc. · Aug 2002
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · Draeger Medical, Inc. · Feb 2002
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663 · Spacelabs Medical, Inc. · Jun 2001