Cleared Traditional

K800763 - MISER INHALATION DEVICE

K800763 is the FDA 510(k) clearance for MISER INHALATION DEVICE by Vix Breathing Equipment Co.. It is a Class 1 Anesthesiology device (product code CCQ) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K800763 · Vix Breathing Equipment Co. · Anesthesiology device
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Apr 1980
Decision
17d
Days
Class 1
Risk

K800763 is an FDA 510(k) clearance for the MISER INHALATION DEVICE, PART NO. 700. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Vix Breathing Equipment Co. (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 17 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 Vix Breathing Equipment Co. devices

Submission Details

510(k) Number K800763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 24, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
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.