Cleared Traditional

CPAP/PRO CPAP INTERFACE (K992384) - FDA 510(k) Clearance

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

K992384 · Stevenson Industries, Inc. · Anesthesiology device
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Dec 1999
Decision
138d
Days
Class 2
Risk

K992384 is an FDA 510(k) clearance for the CPAP/PRO CPAP INTERFACE. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Stevenson Industries, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on December 1, 1999 after a review of 138 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 Stevenson Industries, Inc. devices

Submission Details

510(k) Number K992384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1999
Decision Date December 01, 1999
Days to Decision 138 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 140d · This submission: 138d
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 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K992384.
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · Respironics, Inc. · Sep 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · Puritan Bennett Corp. · Sep 2000
BIPAP DUET LX BI-LEVEL SYSTEM
K000994 · Respironics, Inc. · Jun 2000
RESPIRONICS TOTAL FACE MASK
K992969 · Respironics, Inc. · Nov 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999
VIRTUOSO LX SMART CPAP SYSTEM
K993433 · Respironics, Inc. · Oct 1999