Cleared Traditional

K963994 - NARKOMED GS ANESTHESIA SYSTEM

K963994 is an FDA 510(k) clearance for NARKOMED 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 166-day FDA review.

K963994 · Draeger Medical, Inc. · Anesthesiology device
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Mar 1997
Decision
166d
Days
Class 2
Risk

K963994 is an FDA 510(k) clearance for the NARKOMED 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 March 19, 1997 after a review of 166 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 - K963994

510(k) Number K963994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date March 19, 1997
Days to Decision 166 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
26d slower than avg
Panel avg: 140d · This submission: 166d
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 K963994.
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · Draeger Medical, Inc. · Oct 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · Draeger Medical, Inc. · Sep 1997
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
K965041 · Ohmeda Medical · Jun 1997
OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
K946127 · Ohmeda Medical · Oct 1996
PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
K945463 · Draeger Medical, Inc. · Feb 1995
AS/3 MEMORY MODULE, M0MEM
K945234 · Datex Division Instrumentarium Corp. · Jan 1995