Cleared Traditional

K904344 - SLEEPER MASK SYSTEM

K904344 is the FDA 510(k) clearance for SLEEPER MASK SYSTEM by Devilbiss Health Care, Inc.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K904344 · Devilbiss Health Care, Inc. · Anesthesiology device
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May 1991
Decision
219d
Days
Class 2
Risk

K904344 is an FDA 510(k) clearance for the SLEEPER MASK SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on May 1, 1991 after a review of 219 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Devilbiss Health Care, Inc. devices

Submission Details

510(k) Number K904344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date May 01, 1991
Days to Decision 219 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 140d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 212
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K904344.
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · Respironics, Inc. · Aug 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · Medtronic Vascular · May 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194 · Puritan Bennett Corp. · May 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
K852821 · Puritan Bennett Corp. · Jul 1985
ARGYLE CPAP NASAL CANNULA
K811409 · Sherwood Medical Co. · Jun 1981