Cleared Special

K041622 - MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM

Also marketed or referenced as:
FABIUS TIRO ANESTHESIA SYSTEM

K041622 is an FDA 510(k) clearance for MODIFICATION TO FABIUS GS 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 22-day FDA review.

K041622 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
22d
Days
Class 2
Risk

K041622 is an FDA 510(k) clearance for the MODIFICATION TO FABIUS GS 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 8, 2004 after a review of 22 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 - K041622

510(k) Number K041622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2004
Decision Date July 08, 2004
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K041622.
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419 · Draeger Medical, Inc. · Oct 2004
FABIUS GS ANESTHESIA SYSTEM
K042086 · Draeger Medical, Inc. · Aug 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · Datex-Ohmeda, Inc. · Aug 2004
NARKOMED 6400, MODEL NM6400
K033498 · Draeger Medical, Inc. · Apr 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743 · Datex-Ohmeda, Inc. · Apr 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K030624 · Draeger Medical, Inc. · Mar 2004