Cleared Traditional

K992384 - CPAP/PRO CPAP INTERFACE

K992384 is an FDA 510(k) clearance for CPAP/PRO CPAP INTERFACE, manufactured by Stevenson Industries, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K992384

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.

BZD Device Classification - Class 2, Special Controls

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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K992384.
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SWIVEL ELBOW
K000215 · Engineered Medical Systems · May 2000
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
K990856 · Bird Products Corp. · Jan 2000
RESPIRONICS TOTAL FACE MASK
K992969 · Respironics, Inc. · Nov 1999
IQ NASAL MASK, MODEL P/N 50160
K993269 · Sleepnet Corporation · Oct 1999
ARIA LX CPAP SYSTEM
K993307 · Respironics, Inc. · Oct 1999