Cleared Traditional

K033498 - NARKOMED 6400

K033498 is an FDA 510(k) clearance for NARKOMED 6400, 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 173-day FDA review.

K033498 · Draeger Medical, Inc. · Anesthesiology device
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Apr 2004
Decision
173d
Days
Class 2
Risk

K033498 is an FDA 510(k) clearance for the NARKOMED 6400, MODEL NM6400. 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 April 26, 2004 after a review of 173 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 - K033498

510(k) Number K033498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2003
Decision Date April 26, 2004
Days to Decision 173 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
33d slower than avg
Panel avg: 140d · This submission: 173d
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 K033498.
FABIUS GS ANESTHESIA SYSTEM
K042086 · Draeger Medical, Inc. · Aug 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · Datex-Ohmeda, Inc. · Aug 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K041622 · Draeger Medical, Inc. · Jul 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
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803 · Datex-Ohmeda · Mar 2004