Cleared Traditional

K910239 - NEBU-SOL METERED DOSE DISPENSER (TM) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K910239 · Dey Laboratories, Inc. · Anesthesiology device
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May 1991
Decision
120d
Days
Class 1
Risk

K910239 is an FDA 510(k) clearance for the NEBU-SOL METERED DOSE DISPENSER (TM). Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Dey Laboratories, Inc. (Napa, US). The FDA issued a Cleared decision on May 22, 1991 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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 Dey Laboratories, Inc. devices

Submission Details

510(k) Number K910239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date May 22, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 139d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.