Cleared Traditional

DRAGER-VAPOR 19.3 (K981773) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981773 · Draeger Medical, Inc. · Anesthesiology device
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Jul 1998
Decision
47d
Days
Class 2
Risk

K981773 is an FDA 510(k) clearance for the DRAGER-VAPOR 19.3. 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 July 6, 1998 after a review of 47 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

Submission Details

510(k) Number K981773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1998
Decision Date July 06, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K981773.
Tec 820, Tec 850
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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