Cleared Traditional

K971923 - DRAGER-VAPOR 2000

K971923 is an FDA 510(k) clearance for DRAGER-VAPOR 2000, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K971923 · Draeger Medical, Inc. · Anesthesiology device
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Sep 1997
Decision
116d
Days
Class 2
Risk

K971923 is an FDA 510(k) clearance for the DRAGER-VAPOR 2000. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on September 16, 1997 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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 - K971923

510(k) Number K971923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date September 16, 1997
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 24
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K971923.
DRAGER-VAPOR 19.3
K981773 · Draeger Medical, Inc. · Jul 1998
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DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
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OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · Ohmeda Medical · Oct 1992
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989