Cleared Traditional

K981773 - DRAGER-VAPOR 19.3

K981773 is an FDA 510(k) clearance for DRAGER-VAPOR 19.3, 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 47-day FDA review.

K981773 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K981773

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
Combination Product No
PCCP Authorized No
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.

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 K981773.
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
K000275 · Datex-Ohmeda, Inc. · Apr 2000
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
K990132 · Datex-Ohmeda, Inc. · Jan 1999
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884 · Siemens Medical Solutions USA, Inc. · Aug 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · Draeger Medical, Inc. · May 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051 · Draeger Medical, Inc. · Oct 1997
DRAGER-VAPOR 2000
K971923 · Draeger Medical, Inc. · Sep 1997