Cleared Special

K003579 - NARKOMED MRI-2

K003579 is an FDA 510(k) clearance for NARKOMED MRI-2, 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 63-day FDA review.

K003579 · Draeger Medical, Inc. · Anesthesiology device
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Jan 2001
Decision
63d
Days
Class 2
Risk

K003579 is an FDA 510(k) clearance for the NARKOMED MRI-2, MODEL NM-MRI-2. 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 January 22, 2001 after a review of 63 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 - K003579

510(k) Number K003579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2000
Decision Date January 22, 2001
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K003579.
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
NARKOMED MRI , NM-MRI
K001488 · Draeger Medical, Inc. · Jun 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315 · Siemens Elema AB · May 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · Datex-Ohmeda, Inc. · May 2000