Cleared Traditional

K894244 - DEVILBISS MODEL 8500D AND 8500D-608 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K894244 · Devilbiss Health Care, Inc. · Anesthesiology device
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Oct 1989
Decision
107d
Days
Class 1
Risk

K894244 is an FDA 510(k) clearance for the DEVILBISS MODEL 8500D AND 8500D-608. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 Devilbiss Health Care, Inc. devices

Submission Details

510(k) Number K894244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date October 06, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 139d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.