Cleared Traditional

K905304 - DRESSER ARGUS P/N 1818

K905304 is the FDA 510(k) clearance for DRESSER ARGUS P/N 1818 by Dresser Argus, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K905304 · Dresser Argus, Inc. · Anesthesiology device
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Apr 1991
Decision
140d
Days
Class 2
Risk

K905304 is an FDA 510(k) clearance for the DRESSER ARGUS P/N 1818. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Dresser Argus, Inc. (Brooklyn, US). The FDA issued a Cleared decision on April 17, 1991 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Dresser Argus, Inc. devices

Submission Details

510(k) Number K905304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date April 17, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 33
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K905304.
MOUTH TO MASK RESUSCITATOR
K912625 · Vital Signs, Inc. · Aug 1991
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
K904899 · Vital Signs, Inc. · Jul 1991
MANUAL RESUSCITATOR
K910856 · Vital Signs, Inc. · Jun 1991
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
K903438 · Puritan Bennett Corp. · Aug 1990
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
K903443 · Puritan Bennett Corp. · Aug 1990
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
K903570 · Puritan Bennett Corp. · Aug 1990