Cleared Traditional

K022031 - NARKOMED MRI-2 ANESTHESIA SYSTEM

K022031 is an FDA 510(k) clearance for NARKOMED MRI-2 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 69-day FDA review.

K022031 · Draeger Medical, Inc. · Anesthesiology device
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Aug 2002
Decision
69d
Days
Class 2
Risk

K022031 is an FDA 510(k) clearance for the NARKOMED MRI-2 ANESTHESIA SYSTEM, 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 August 29, 2002 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K022031

510(k) Number K022031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2002
Decision Date August 29, 2002
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
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 K022031.
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
FABIUS TIRO ANESTHESIA SYSTEM
K031400 · Draeger Medical, Inc. · Jul 2003
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-2, MODEL NM-MRI-2
K003579 · Draeger Medical, Inc. · Jan 2001