Cleared Traditional

K011404 - FABIUS GS ANESTHESIA SYSTEM

K011404 is an FDA 510(k) clearance for FABIUS GS ANESTHESIA SYSTEM, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K011404 · Draeger Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
290d
Days
Class 2
Risk

K011404 is an FDA 510(k) clearance for the FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS. 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 February 22, 2002 after a review of 290 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K011404

510(k) Number K011404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date February 22, 2002
Days to Decision 290 days
Submission Type Traditional
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
150d slower than avg
Panel avg: 140d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011404.
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K030939 · Philips Medical Systems · Jul 2003
FABIUS TIRO ANESTHESIA SYSTEM
K031400 · Draeger Medical, Inc. · Jul 2003
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031 · Draeger Medical, Inc. · Aug 2002
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663 · Spacelabs Medical, Inc. · Jun 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · Draeger Medical, Inc. · Jan 2001
NARKOMED MRI , NM-MRI
K001488 · Draeger Medical, Inc. · Jun 2000