Cleared Traditional

K931952 - MEDWAY OXYGEN MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K931952 · Medway · Anesthesiology device
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Aug 1993
Decision
122d
Days
Class 1
Risk

K931952 is an FDA 510(k) clearance for the MEDWAY OXYGEN MASK. Classified as Mask, Oxygen (product code BYG), Class I - General Controls.

Submitted by Medway (Franklin, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5580 - 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 Medway devices

Submission Details

510(k) Number K931952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date August 20, 1993
Days to Decision 122 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
17d faster than avg
Panel avg: 139d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYG Mask, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5580
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.