Cleared Traditional

K942055 - DRAGER-VAPOR 19.1

K942055 is the FDA 510(k) clearance for DRAGER-VAPOR 19.1 by North American Grager. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K942055 · North American Grager · Anesthesiology device
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Jan 1995
Decision
274d
Days
Class 2
Risk

K942055 is an FDA 510(k) clearance for the DRAGER-VAPOR 19.1. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by North American Grager (Telford, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 274 days - an extended review 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: 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 North American Grager devices

Submission Details

510(k) Number K942055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date January 27, 1995
Days to Decision 274 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 140d · This submission: 274d
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 15
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K942055.
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051 · Draeger Medical, Inc. · Oct 1997
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
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989