Cleared Traditional

K973051 - DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS

K973051 is an FDA 510(k) clearance for DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS, 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 76-day FDA review.

K973051 · Draeger Medical, Inc. · Anesthesiology device
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Oct 1997
Decision
76d
Days
Class 2
Risk

K973051 is an FDA 510(k) clearance for the DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS. 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 October 30, 1997 after a review of 76 days - a notably fast clearance cycle.

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: 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 - K973051

510(k) Number K973051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date October 30, 1997
Days to Decision 76 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
64d faster than avg
Panel avg: 140d · This submission: 76d
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 K973051.
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884 · Siemens Medical Solutions USA, Inc. · Aug 1998
DRAGER-VAPOR 19.3
K981773 · Draeger Medical, Inc. · Jul 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · Draeger Medical, Inc. · May 1998
DRAGER-VAPOR 2000
K971923 · Draeger Medical, Inc. · Sep 1997
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
K942091 · Ohmeda Medical · Mar 1995
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · Ohmeda Medical · Oct 1992