Cleared Traditional

K832512 - AIRWAY MASKS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K832512 · Artec Environmental Monitoring Division · Anesthesiology device
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Jan 1984
Decision
174d
Days
Class 1
Risk

K832512 is an FDA 510(k) clearance for the AIRWAY MASKS. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Artec Environmental Monitoring Division (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 174 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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 Artec Environmental Monitoring Division devices

Submission Details

510(k) Number K832512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date January 17, 1984
Days to Decision 174 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 139d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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.