Cleared Traditional

K933184 - POSITIVE AIRWAY PRESSURE SYSTEM

K933184 is the FDA 510(k) clearance for POSITIVE AIRWAY PRESSURE SYSTEM by Innovative Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 516-day FDA review.

K933184 · Innovative Medical Systems, Inc. · Anesthesiology device
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Nov 1994
Decision
516d
Days
Class 2
Risk

K933184 is an FDA 510(k) clearance for the POSITIVE AIRWAY PRESSURE SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Innovative Medical Systems, Inc. (Hampton, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 516 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Innovative Medical Systems, Inc. devices

Submission Details

510(k) Number K933184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1993
Decision Date November 28, 1994
Days to Decision 516 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
376d slower than avg
Panel avg: 140d · This submission: 516d
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 247
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K933184.
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
K950331 · Healthdyne, Inc. · Sep 1995
SPECTRUM(TM) MASK
K936047 · Respironics, Inc. · Mar 1995
PURITAN-BENNETT COMPANION 320 I/E
K934804 · Puritan Bennett Corp. · Feb 1995
NASAL/ORAL MASK
K925587 · Respironics, Inc. · Sep 1993
TOTAL FACE MASK
K925920 · Respironics, Inc. · Jul 1993
318A RESPIRATORY SUPPORT SYSTEM
K923590 · Puritan Bennett Corp. · Apr 1993