Cleared Traditional

SLEEPAP (K905593) - FDA 510(k) Clearance

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

K905593 · Medical Industries America, Inc. · Anesthesiology device
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Apr 1991
Decision
131d
Days
Class 2
Risk

K905593 is an FDA 510(k) clearance for the SLEEPAP. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on April 23, 1991 after a review of 131 days - within the typical 510(k) review window.

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 Medical Industries America, Inc. devices

Submission Details

510(k) Number K905593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date April 23, 1991
Days to Decision 131 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 140d · This submission: 131d
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 131
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K905593.
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