Cleared Traditional

K841989 - ARM-A-VIAL LV SODIUM CHLORIDE INHALAT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K841989 · Armour Pharmaceutical Co. · Anesthesiology device
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Jul 1984
Decision
79d
Days
Class 1
Risk

K841989 is an FDA 510(k) clearance for the ARM-A-VIAL LV SODIUM CHLORIDE INHALAT. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Armour Pharmaceutical Co. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 79 days - a notably fast clearance cycle.

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: 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 Armour Pharmaceutical Co. devices

Submission Details

510(k) Number K841989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1984
Decision Date July 27, 1984
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 139d · This submission: 79d
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.