Cleared Traditional

K932347 - COMPACT MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K932347 · Vital Signs, Inc. · Anesthesiology device
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Jan 1994
Decision
241d
Days
Class 1
Risk

K932347 is an FDA 510(k) clearance for the COMPACT MASK. Classified as Mask, Oxygen, Non-rebreathing (product code KGB), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on January 10, 1994 after a review of 241 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5570 - 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K932347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1993
Decision Date January 10, 1994
Days to Decision 241 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 139d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGB Mask, Oxygen, Non-rebreathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5570
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.