Cleared Traditional

K896090 - DEVILBISS MODEL 6300D (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K896090 · Devilbiss Health Care, Inc. · Ear, Nose, Throat device
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Nov 1989
Decision
42d
Days
Class 1
Risk

K896090 is an FDA 510(k) clearance for the DEVILBISS MODEL 6300D. Classified as Pump, Nebulizer, Manual (product code EPN), Class I - General Controls.

Submitted by Devilbiss Health Care, Inc. (Somerset, US). The FDA issued a Cleared decision on November 30, 1989 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - the FDA ear, nose and throat 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devilbiss Health Care, Inc. devices

Submission Details

510(k) Number K896090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date November 30, 1989
Days to Decision 42 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 89d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EPN Pump, Nebulizer, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.