Cleared Traditional

K993492 - DEVILBISS NEBULIZER MODEL 800

K993492 is an FDA 510(k) clearance for DEVILBISS NEBULIZER MODEL 800, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K993492 · Sunrise Medical Hhg, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
189d
Days
Class 2
Risk

K993492 is an FDA 510(k) clearance for the DEVILBISS NEBULIZER MODEL 800. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on April 21, 2000 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Sunrise Medical Hhg, Inc. devices

FDA 510(k) Submission Details - K993492

510(k) Number K993492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date April 21, 2000
Days to Decision 189 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
49d slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 259
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K993492.
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K991355 · Instrumentation Industries, Inc. · Jan 2000
SALTER AIRE COMPRESSOR
K992285 · Salter Labs · Jan 2000
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · Invacare Corp. · Oct 1999